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FDA 510(k)

FUJI UM MAMMO SERIES INTENSIFY SCREENS:

K-Number: K943822 · 1994-08-22

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1994-08-22
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI UM MAMMO SERIES INTENSIFY SCREENS: is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K943822. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI UM MAMMO SERIES INTENSIFY SCREENS:?

FUJI UM MAMMO SERIES INTENSIFY SCREENS: is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K943822.

When did FUJI UM MAMMO SERIES INTENSIFY SCREENS: receive FDA 510(k) clearance?

FUJI UM MAMMO SERIES INTENSIFY SCREENS: received FDA 510(k) clearance on 1994-08-22, under 510(k) number K943822.

Who is the listed applicant for FUJI UM MAMMO SERIES INTENSIFY SCREENS:?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI UM MAMMO SERIES INTENSIFY SCREENS:?

The FDA product code for FUJI UM MAMMO SERIES INTENSIFY SCREENS: is EAM.

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Other records listing Fujifilm Medical System U.S.A., 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.

K163675Processor VP-7000, Light Source BL-7000K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)K132188MAMMOGRAPHY VIEWER SMV658K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISK130383SYNAPSE 3D CARDIAC TOOLS

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Related Devices (Code: EAM)

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.

K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.K942235KYOKKO GREEN SERIES INTENSIFYING SCREENSFujifilm Medical System U.S.A., 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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