Clearance Summary
UC-5000 Mobile X-Ray received FDA 510(k) clearance under submission number K163063, sponsored by Source-Ray, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-12-12.
- Submission: K163063
- Applicant / Sponsor: Source-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 2016-12-12
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.