DuraDiagnost 712214
GUDID 00884838064751
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
Stationary basic diagnostic x-ray system, digital| Primary Device ID | 00884838064751 |
| NIH Device Record Key | a9aa1a94-ad66-497b-9c00-45ad1a6746fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraDiagnost |
| Version Model Number | 712214 |
| Catalog Number | 712214 |
| Company DUNS | 421265537 |
| Company Name | Philips Healthcare (Suzhou) Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838064751 [Primary] |
FDA Product Code
| MQB | Solid state x-ray imager (flat panel/digital imager) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [DuraDiagnost]
| 00884838064751 | The DuraDiagnost is intended for use in generating radiographic images of human anatomy by quali |
| 00884838095205 | Stationary x-ray system |
Trademark Results [DuraDiagnost]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURADIAGNOST 79114722 4441771 Live/Registered |
Koninklijke Philips N.V. 2012-05-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.