The following data is part of a premarket notification filed by Eos Imaging with the FDA for Eos System.
| Device ID | K152788 |
| 510k Number | K152788 |
| Device Name: | EOS System |
| Classification | System, X-ray, Stationary |
| Applicant | EOS IMAGING 10 RUE MERCOEUR Paris, FR |
| Contact | Mathias Breuil |
| Correspondent | John J Smith HOGAN LOVELLS US L.L.P. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2015-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663999000016 | K152788 | 000 |
| 03663999000009 | K152788 | 000 |