The following data is part of a premarket notification filed by Eos Imaging with the FDA for Stereos Workstation.
| Device ID | K172346 |
| 510k Number | K172346 |
| Device Name: | SterEOS Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | EOS Imaging 10 Rue Mercoeur Paris, FR 75011 |
| Contact | Mathias Breuil |
| Correspondent | Mathias Breuil EOS Imaging 10 Rue Mercoeur Paris, FR 75011 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2018-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663999000153 | K172346 | 000 |