Zenition 718134
GUDID 00884838112292
Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed
Philips Medical Systems Nederland B.V.
Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital Mobile general-purpose fluoroscopic x-ray system, digital| Primary Device ID | 00884838112292 |
| NIH Device Record Key | 03120c8a-8520-47cb-8940-64af4da83f06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zenition |
| Version Model Number | Zenition 90 |
| Catalog Number | 718134 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 110 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838112292 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240224
FDA Product Code
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-05 |
| Device Publish Date | 2024-05-28 |
On-Brand Devices [Zenition]
| 00884838091535 | The Zenition 50 with image intensifier is a mobile X-ray imaging and viewing system. It is desig |
| 00884838091528 | The Zenition 70 with flat detector is a mobile X-ray imaging and viewing system. It is designed |
| 00884838112292 | Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical |
Trademark Results [Zenition]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENITION 79243879 5809404 Live/Registered |
Koninklijke Philips N.V. 2018-08-21 |
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