Clearance Summary
CADIMAS VERSION 1.0 received FDA 510(k) clearance under submission number K052023, sponsored by Alan Penn & Associates., 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 2005-12-08.
- Submission: K052023
- Applicant / Sponsor: Alan Penn & Associates., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2005-12-08
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.