Uc-Care Navigo Sytem
by Uc-Care Ltd
510(k) K100784
Uc-Care Navigo Sytem is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Uc-Care Ltd, cleared under FDA 510(k) K100784 on 1 Nov 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100784 | Date1 Nov 2011 | StatusActive |
Official records
- FDA 510(k) database K100784
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- UC-CARE , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K100784
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Ascension transmitter Cubic Assembly ASMCH00034 | ASMCH00034 / ASMCH00034 | 07290016936100 | — | On the market |
| Civco classic stepper sensor fixator FPRSA00022 | FPRSA00022 / FPRSA00022 | 07290016936193 | — | On the market |
| Computer (Industrial) FPRCO00011 | FPRCO00011 / FPRCO00011 | 07290016936018 | — | On the market |
| D&K Stepper template fixator FPRSA00021 | FPRSA00021 / FPRSA00021 | 07290016936186 | — | On the market |
| Endocar Tamplate Fixator FPRSA00023 | FPRSA00023 / FPRSA00023 | 07290016936209 | — | On the market |
| Navigo™ Workstation FPRMC0016A | FPRMC0016A / FPRMC0016A | 07290016936001 | — | On the market |
| Probe sensor assembly for BK 8667 (square) FPRSA00011 | FPRSA00011 / FPRSA00011 | 07290016936063 | — | On the market |
| Probe sensor assembly for BK 8808 (square) FPRSA00006 | FPRSA00006 / FPRSA00006 | 07290016936025 | — | On the market |
| Probe sensor assembly for BK 8818 and 8808e (square) FPRSA00007 | FPRSA00007 / FPRSA00007 | 07290016936032 | — | On the market |
| Probe sensor assembly for Civco 8848 FPRSA00017 | FPRSA00017 / FPRSA00017 | 07290016936148 | — | On the market |
| Probe sensor assembly for D&K 8848 FPRSA00016 | FPRSA00016 / FPRSA00016 | 07290016936131 | — | On the market |
| Probe sensor assembly for EndoCare FPRSA00015 | FPRSA00015 / FPRSA00015 | 07290016936124 | — | On the market |
| Probe sensor assembly for GE BE9CS FPRSA00019 | FPRSA00019 / FPRSA00019 | 07290016936162 | — | On the market |
| Probe sensor assembly for GE E8CS (square) FPRSA00009 | FPRSA00009 / FPRSA00009 | 07290016936056 | — | On the market |
| Probe sensor assembly for GE E8CS FPRSA00014 | FPRSA00014 / FPRSA00014 | 07290016936087 | — | On the market |
| Probe sensor assembly for Hitachi EUP-U533 FPRSA00018 | FPRSA00018 / FPRSA00018 | 07290016936155 | — | On the market |
| Probe sensor assembly for Hitachi V53W (square) FPRSA00008 | FPRSA00008 / FPRSA00008 | 07290016936049 | — | On the market |
| Probe sensor assembly for Hitachi V53W FPRSA00012 | FPRSA00012 / FPRSA00012 | 07290016936094 | — | On the market |
| Probe sensor assembly for MindRay FPRSA00013 | FPRSA00013 / FPRSA00013 | 07290016936070 | — | On the market |
| Probe sensor assembly for Philips BP10-5es FPRSA00020 | FPRSA00020 / FPRSA00020 | 07290016936179 | — | On the market |
| Probe sensor FPRSA00024 | FPRSA00024 / FPRSA00024 | 07290016936216 | — | On the market |
| Roll Stand + Arm HRDGN00023 | HRDGN00023 / HRDGN00023 | 07290016936117 | — | On the market |
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