AFFIRM BREAST BIOPSY GUIDANCE SYSTEM— 510(k) K122836

Substantially Equivalent

Lorad, A Hologic Co.

FDA 510(k) clearance K122836 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, Substantially Equivalent on 2013-01-11. Applicant: Lorad, A Hologic Co..

Clearance details

Applicant
Lorad, A Hologic Co.
Product code
Code IZH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Danbury, CT, US
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