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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2020-10-05 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K202294.

When did Affirm Contrast Biopsy receive FDA 510(k) clearance?

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

Who is the listed applicant for Affirm Contrast Biopsy?

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 Contrast Biopsy?

The FDA product code for Affirm Contrast Biopsy is IZH.

Related Clinical Trials

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.

NCT06636539Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational DeviceACTIVE_NOT_RECRUITINGNCT05199701Prospective Case Collection Study for New Mammography TechnologiesACTIVE_NOT_RECRUITING

Other records listing Hologic, Inc. as applicant

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.

K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)K253634CoolSeal Generator® (CSL-200-90)PMA P920048ENZYME IMMUNOASSAY, FETAL FIBRONECTINPMA P010013Device, thermal ablation, endometrialPMA P080003Digital breast tomosynthesisPMA P170025Hepatitis Viral B DNA Detection

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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.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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