Navigo Workstation Version 2.0
by Uc-Care Ltd
510(k) K173054
Navigo Workstation Version 2.0 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) K173054 on 16 Jan 2018, 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 | NumberK173054 | Date16 Jan 2018 | StatusActive |
Official records
- FDA 510(k) database K173054
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- Withdrawn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
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- DTX Studio diagnose by Nobel Biocare AB
- QCA PLUS by Sanders Data Systems, LLC
- Sterile Sheath for CONVIVO 302732-0530-000 by Carl Zeiss Meditec AG
- PROVIEW MEDICAL IMAGE DISPLAY MODULE by Cerner Corporation
- Surgical Planning Software version 1.1 by ORTHO KINEMATICS, INC.
- VISUALASE ENVISION SOFTWARE SYSTEM by BIOTEX, INC.
- VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER by Vidistar, LLC
- Blackford Analysis Registration Product Family by Blackford Analysis, Ltd.
- KODAK CARESTREAM PACS by EASTMAN KODAK COMPANY
- SYNAPSE 3D TENSOR ANALYSIS by Fujifilm Meidcal Systems U.S.A., Inc.