The following data is part of a premarket notification filed by Onefit Medical with the FDA for Hipeos.
| Device ID | K161479 |
| 510k Number | K161479 |
| Device Name: | HipEOS |
| Classification | System, Image Processing, Radiological |
| Applicant | ONEFIT MEDICAL 18 RUE ALAIN SAVARY Besancon, FR 25000 |
| Contact | Julien Simon |
| Correspondent | Julien Simon ONEFIT MEDICAL 18 RUE ALAIN SAVARY Besancon, FR 25000 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-06-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HIPEOS 79313158 not registered Live/Pending |
EOS IMAGING 2021-04-13 |