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FDA 510(k)

BIOPSY POSITIONER

K-Number: K113284 · 2012-03-07

ApplicantFuji Film Medical Systems
Decision Date2012-03-07
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Film Medical Systems. It received FDA 510(k) clearance on 2012-03-07 under 510(k) number K113284. 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 BIOPSY POSITIONER?

BIOPSY POSITIONER is a medical device that received FDA 510(k) clearance on 2012-03-07. The listed applicant is Fuji Film Medical Systems. The 510(k) number is K113284.

When did BIOPSY POSITIONER receive FDA 510(k) clearance?

BIOPSY POSITIONER received FDA 510(k) clearance on 2012-03-07, under 510(k) number K113284.

Who is the listed applicant for BIOPSY POSITIONER?

The FDA 510(k) record lists Fuji Film Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY POSITIONER?

The FDA product code for BIOPSY POSITIONER is IZH.

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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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