Affirm Prone Biopsy System— 510(k) K153486

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K153486 for Affirm Prone Biopsy System, Substantially Equivalent on 2016-04-01. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2015-12-04
Decision date: 2016-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.