K250664
- 510(k) number
- K250664
- Device name
- Navigo Workstation 2.3 (FPRMC00039)
- Applicant
- UC-CARE , Ltd. IL
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-07
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250664.pdf
Official FDA record: K250664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.