510(k) K202294— Affirm Contrast Biopsy

Substantially Equivalent

Hologic, Inc.

Clearance details

Applicant: Hologic, Inc.
Product code: Code IZH
Advisory panel: Radiology
Date received: 2020-08-13
Decision date: 2020-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

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