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FDA 510(k)

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

K-Number: K103512 · 2011-01-07

ApplicantHologic, Inc.
Decision Date2011-01-07
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K103512. 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 BREAST BIOPSY GUIDANCE SYSTEM?

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Hologic, Inc.. The 510(k) number is K103512.

When did AFFIRM BREAST BIOPSY GUIDANCE SYSTEM receive FDA 510(k) clearance?

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM received FDA 510(k) clearance on 2011-01-07, under 510(k) number K103512.

Who is the listed applicant for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM?

The FDA product code for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is IZH.

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Other records listing Hologic, Inc. as applicant

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Related Devices (Code: IZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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