Clearance Summary
CPI RAD VISION received FDA 510(k) clearance under submission number K122726, sponsored by Communications & Power Industries Canada, 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 2013-02-15.
- Submission: K122726
- Applicant / Sponsor: Communications & Power Industries Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2013-02-15
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.