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FDA 510(k)

CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR

K-Number: K925725 · 1993-02-26

ApplicantBennett X-Ray Corp.
Decision Date1993-02-26
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR is the device name listed in this FDA 510(k) record. The listed applicant is Bennett X-Ray Corp.. It received FDA 510(k) clearance on 1993-02-26 under 510(k) number K925725. 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 CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR?

CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR is a medical device that received FDA 510(k) clearance on 1993-02-26. The listed applicant is Bennett X-Ray Corp.. The 510(k) number is K925725.

When did CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR receive FDA 510(k) clearance?

CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR received FDA 510(k) clearance on 1993-02-26, under 510(k) number K925725.

Who is the listed applicant for CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR?

The FDA 510(k) record lists Bennett X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR?

The FDA product code for CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR is IZH.

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Other records listing Bennett X-Ray Corp. 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.

K964576PROFILE MAMMOGRAPHY SYSTEM (M-PRO)K952672VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEMK944978BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSIK945962BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHYK945731HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORSK945749BENNETT X-RAY TOMOGRAPHY SYSTEM

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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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