EOSedge
System, X-ray, Stationary
EOS Imaging
The following data is part of a premarket notification filed by Eos Imaging with the FDA for Eosedge.
Pre-market Notification Details
| Device ID | K202394 |
| 510k Number | K202394 |
| Device Name: | EOSedge |
| Classification | System, X-ray, Stationary |
| Applicant | EOS Imaging 10 Rue Mercoeur Paris, FR F-75011 |
| Contact | Bernard Ismael |
| Correspondent | Bernard Ismael EOS Imaging 10 Rue Mercoeur Paris, FR F-75011 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2020-09-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663999000108 | K202394 | 000 |
Trademark Results [EOSedge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EOSEDGE 97438566 not registered Live/Pending |
EOS Imaging SA 2022-06-01 |
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