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FDA 510(k)

Affirm Prone Biopsy System

K-Number: K153486 · 2016-04-01

ApplicantHologic, Inc.
Decision Date2016-04-01
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Affirm Prone Biopsy System is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2016-04-01 under approval number K153486. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Affirm Prone Biopsy System?

Affirm Prone Biopsy System is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Hologic, Inc.. The 510(k) number is K153486.

When was Affirm Prone Biopsy System approved by the FDA?

Affirm Prone Biopsy System received FDA 510(k) clearance on 2016-04-01, under approval number K153486.

What company makes Affirm Prone Biopsy System?

Affirm Prone Biopsy System is manufactured by Hologic, Inc..

What is the FDA product code for Affirm Prone Biopsy System?

The FDA product code for Affirm Prone Biopsy System is IZH.

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Related Devices (Code: IZH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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