510(k) K250664
K250664 is an FDA 510(k) premarket notification submitted by UC-CARE , Ltd. for the device "Navigo Workstation 2.3 (FPRMC00039)". The FDA issued a decision of Substantially Equivalent on Aug 7, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. UC-CARE , Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 7, 2025
- Date Received
- Mar 5, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)