sterEOS®
GUDID 03663999000023
sterEOS workstation
EOS IMAGING
Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software| Primary Device ID | 03663999000023 |
| NIH Device Record Key | 853a153a-4ecc-4291-bd1a-0c8d5face51c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sterEOS® |
| Version Model Number | Workstation 1.6 |
| Company DUNS | 762320968 |
| Company Name | EOS IMAGING |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com | |
| Phone | 8669335301 |
| contact@eos-imaging.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663999000023 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141137
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [sterEOS®]
| 03663999000023 | sterEOS workstation |
| 03663999000054 | sterEOS workstation software |
| 03663999000047 | sterEOS workstation |
| 03663999000030 | sterEOS workstation software |
Trademark Results [sterEOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEREOS 86632974 not registered Dead/Abandoned |
Mass Fidelity Inc. 2015-05-18 |
 STEREOS 79062307 3825206 Live/Registered |
EOS IMAGING 2008-05-16 |
 STEREOS 74673429 1999387 Dead/Cancelled |
EOS GmbH Electro Optical Systems 1995-05-12 |
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