Clearance Summary
SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY received FDA 510(k) clearance under submission number K850614, sponsored by S & S X-Ray Products, 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 1985-03-26.
- Submission: K850614
- Applicant / Sponsor: S & S X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1985-03-26
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.