The following data is part of a premarket notification filed by Uc-care Ltd. with the FDA for Uc-care Navigo Sytem.
| Device ID | K100784 |
| 510k Number | K100784 |
| Device Name: | UC-CARE NAVIGO SYTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | UC-CARE LTD. 555 THIRTEENTH STREET NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | John Kahan |
| Correspondent | John Kahan UC-CARE LTD. 555 THIRTEENTH STREET NW COLUMBIA SQUARE 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 | 2010-03-19 |
| Decision Date | 2011-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016936216 | K100784 | 000 |
| 07290016936094 | K100784 | 000 |
| 07290016936087 | K100784 | 000 |
| 07290016936070 | K100784 | 000 |
| 07290016936063 | K100784 | 000 |
| 07290016936056 | K100784 | 000 |
| 07290016936049 | K100784 | 000 |
| 07290016936032 | K100784 | 000 |
| 07290016936025 | K100784 | 000 |
| 07290016936018 | K100784 | 000 |
| 07290016936100 | K100784 | 000 |
| 07290016936117 | K100784 | 000 |
| 07290016936209 | K100784 | 000 |
| 07290016936193 | K100784 | 000 |
| 07290016936186 | K100784 | 000 |
| 07290016936179 | K100784 | 000 |
| 07290016936162 | K100784 | 000 |
| 07290016936155 | K100784 | 000 |
| 07290016936148 | K100784 | 000 |
| 07290016936131 | K100784 | 000 |
| 07290016936124 | K100784 | 000 |
| 07290016936001 | K100784 | 000 |