Clearance Summary
Navigo Workstation Version 2.0 received FDA 510(k) clearance under submission number K173054, sponsored by UC-CARE , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-01-16.
- Submission: K173054
- Applicant / Sponsor: UC-CARE , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2018-01-16
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.