The following data is part of a premarket notification filed by Uc-care Ltd. with the FDA for Uc-care Navigo Workstation.
| Device ID | K160934 |
| 510k Number | K160934 |
| Device Name: | UC-CARE NaviGo Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | UC-CARE LTD. APOLLO BLDG., NEW INDUSTRIAL ZONE, P.O. BOX 67 Yokneam, IL 20692 |
| Contact | Tomer Schatzberger |
| Correspondent | John Smith H.M. DA LTD Columbia Square 555 Thirteenth Street, 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 | 2016-04-04 |
| Decision Date | 2017-02-06 |
| Summary: | summary |