Skip to content
Scan

Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K103512

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM · Hologic, Inc. · decided 2011-01-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
AFFIRM™ CONTRAST BIOPSYAFFIRM™ CONTRAST BIOPSY SOFTWAREHologic, Inc.IZH15420045512948