sterEOS®
GUDID 03663999000030
sterEOS workstation software
EOS IMAGING
Radiology DICOM image processing application software| Primary Device ID | 03663999000030 |
| NIH Device Record Key | 514084a9-2fa8-4524-ad5d-20471168db7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sterEOS® |
| Version Model Number | Software 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663999000030 [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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