Clearance Summary
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES received FDA 510(k) clearance under submission number K050728, sponsored by Usa Instruments, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-06-28.
- Submission: K050728
- Applicant / Sponsor: Usa Instruments, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2005-06-28
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.