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FDA 510(k)

PROFILE MAMMOGRAPHY SYSTEM (M-PRO)

K-Number: K964576 · 1997-01-10

ApplicantBennett X-Ray Corp.
Decision Date1997-01-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROFILE MAMMOGRAPHY SYSTEM (M-PRO) 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 1997-01-10 under 510(k) number K964576. 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 PROFILE MAMMOGRAPHY SYSTEM (M-PRO)?

PROFILE MAMMOGRAPHY SYSTEM (M-PRO) is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Bennett X-Ray Corp.. The 510(k) number is K964576.

When did PROFILE MAMMOGRAPHY SYSTEM (M-PRO) receive FDA 510(k) clearance?

PROFILE MAMMOGRAPHY SYSTEM (M-PRO) received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964576.

Who is the listed applicant for PROFILE MAMMOGRAPHY SYSTEM (M-PRO)?

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 PROFILE MAMMOGRAPHY SYSTEM (M-PRO)?

The FDA product code for PROFILE MAMMOGRAPHY SYSTEM (M-PRO) 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.

K952672VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEMK944978BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSIK945962BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHYK945749BENNETT X-RAY TOMOGRAPHY SYSTEMK945731HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORSK940701BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH

View all 23 devices →

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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