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FDA 510(k)

Affirm Contrast Biopsy

K-Number: K202294 · 2020-10-05

ApplicantHologic, Inc.
Decision Date2020-10-05
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Affirm Contrast Biopsy is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2020-10-05 under approval number K202294. 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 Contrast Biopsy?

Affirm Contrast Biopsy is a medical device that received FDA 510(k) clearance on 2020-10-05. It is manufactured by Hologic, Inc.. The 510(k) number is K202294.

When was Affirm Contrast Biopsy approved by the FDA?

Affirm Contrast Biopsy received FDA 510(k) clearance on 2020-10-05, under approval number K202294.

What company makes Affirm Contrast Biopsy?

Affirm Contrast Biopsy is manufactured by Hologic, Inc..

What is the FDA product code for Affirm Contrast Biopsy?

The FDA product code for Affirm Contrast Biopsy is IZH.

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Related Devices (Code: IZH)

K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic K161920Comfort CoverPrecision Dynamics Corporation K153486Affirm Prone Biopsy SystemHologic, Inc. K191495Biopsy PositionerFujifilm Corporation K203509SMART FINDERIms Giotto S.P.A.

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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