Clearance Summary
CAAS QCA 3D received FDA 510(k) clearance under submission number K063344, sponsored by Pie Medical Imaging BV. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-11-28.
- Submission: K063344
- Applicant / Sponsor: Pie Medical Imaging BV
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2006-11-28
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.