Navigo™ Workstation FPRMC0016A
by Uc-Care Ltd
Navigo Workstation FPRMC0016A is a rectal ultrasound navigational image processor (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 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 07290016936001), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016936001 | Date15 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100784 | Date1 Nov 2011 | StatusActive |
Official records
- AccessGUDID record 07290016936001
- FDA 510(k) database K100784
Across registries
- FDA 510(k) K100784 decided 1 Nov 2011 Active
- FDA GUDID UDI-DI 07290016936001 listed 15 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K100784
- Listed FDA GUDID 07290016936001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Navigo™ Workstation
- Generic name
- Rectal ultrasound navigational image processor
- Model / Ref / Catalog
- FPRMC0016A
- Primary DI / UDI-DI
- 07290016936001
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Rectal ultrasound navigational image processor
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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