Clearance Summary
CPIVISION DIGITAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K061173, 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 2006-06-09.
- Submission: K061173
- Applicant / Sponsor: Communications & Power Industries Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2006-06-09
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.