The following data is part of a premarket notification filed by Eos Imaging, Inc. with the FDA for Stereos Workstation.
| Device ID | K160914 |
| 510k Number | K160914 |
| Device Name: | SterEOS Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | EOS IMAGING, INC. 10 RUE MERCOEUR Paris, FR |
| Contact | Mathias Breuil |
| Correspondent | John J. Smith HOGAN LOVELLS U.S. L.L.P. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-04-22 |
| Summary: | summary |