Clearance Summary
PROFILE MAMMOGRAPHY SYSTEM (M-PRO) received FDA 510(k) clearance under submission number K964576, sponsored by Bennett X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-01-10.
- Submission: K964576
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1997-01-10
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.