The following data is part of a premarket notification filed by Uc-care Ltd. with the FDA for Navigo Workstation Version 2.0.
| Device ID | K173054 |
| 510k Number | K173054 |
| Device Name: | Navigo Workstation Version 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | UC-Care Ltd. Apollo Bldg.,New Industrial Zone, P.O.Box 67 Yokneam, IL 20692 |
| Contact | Hadas Sheynise |
| Correspondent | John Smith Hogan Lovells US LLP 555 13th Sreet NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-01-16 |
| Summary: | summary |