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FDA 510(k)

BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY

K-Number: K945962 · 1995-04-03

ApplicantBennett X-Ray Corp.
Decision Date1995-04-03
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY 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 1995-04-03 under 510(k) number K945962. 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 BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY?

BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY is a medical device that received FDA 510(k) clearance on 1995-04-03. The listed applicant is Bennett X-Ray Corp.. The 510(k) number is K945962.

When did BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY receive FDA 510(k) clearance?

BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY received FDA 510(k) clearance on 1995-04-03, under 510(k) number K945962.

Who is the listed applicant for BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY?

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 BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY?

The FDA product code for BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY 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-DSIK945731HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORSK945749BENNETT X-RAY TOMOGRAPHY SYSTEMK940701BENNETT 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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