Clearance Summary
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM received FDA 510(k) clearance under submission number K122836, sponsored by Lorad, A Hologic Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-01-11.
- Submission: K122836
- Applicant / Sponsor: Lorad, A Hologic Co.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 2013-01-11
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.