Clearance Summary
CPI RAD VISION, MODEL VZW2944XX-YY received FDA 510(k) clearance under submission number K083224, 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 2009-03-24.
- Submission: K083224
- 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: 2009-03-24
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.