AFFIRM BREAST BIOPSY GUIDANCE SYSTEM— 510(k) K103512

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K103512 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, Substantially Equivalent on 2011-01-07. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code IZH
Advisory panel: Radiology
Date received: 2010-11-30
Decision date: 2011-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

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