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FDA 510(k)

Affirm Lateral Arm Upright Biopsy Accessory

K-Number: K161575 · 2016-08-10

ApplicantHologic
Decision Date2016-08-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Affirm Lateral Arm Upright Biopsy Accessory is a medical device manufactured by Hologic. It received FDA 510(k) clearance on 2016-08-10 under approval number K161575. 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 Lateral Arm Upright Biopsy Accessory?

Affirm Lateral Arm Upright Biopsy Accessory is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Hologic. The 510(k) number is K161575.

When was Affirm Lateral Arm Upright Biopsy Accessory approved by the FDA?

Affirm Lateral Arm Upright Biopsy Accessory received FDA 510(k) clearance on 2016-08-10, under approval number K161575.

What company makes Affirm Lateral Arm Upright Biopsy Accessory?

Affirm Lateral Arm Upright Biopsy Accessory is manufactured by Hologic.

What is the FDA product code for Affirm Lateral Arm Upright Biopsy Accessory?

The FDA product code for Affirm Lateral Arm Upright Biopsy Accessory is IZH.

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Related PubMed Literature

PMID: 30844339 Introduction to Currently Applied Device Pathology. Toxicologic pathology (2019)

Other Devices by Hologic

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Related Devices (Code: IZH)

K161920Comfort CoverPrecision Dynamics Corporation K153486Affirm Prone Biopsy SystemHologic, Inc. K191495Biopsy PositionerFujifilm Corporation K202294Affirm Contrast BiopsyHologic, Inc. 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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