Clearance Summary
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 received FDA 510(k) clearance under submission number K885135, 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 1989-03-09.
- Submission: K885135
- Applicant / Sponsor: Bennett X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1989-03-09
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.