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FDA 510(k)

FUJI MEDICAL FILM PROCESSOR FPM2800

K-Number: K935957 · 1994-01-31

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1994-01-31
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI MEDICAL FILM PROCESSOR FPM2800 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 1994-01-31 under 510(k) number K935957. The device is classified under product code IXW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI MEDICAL FILM PROCESSOR FPM2800?

FUJI MEDICAL FILM PROCESSOR FPM2800 is a medical device that received FDA 510(k) clearance on 1994-01-31. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K935957.

When did FUJI MEDICAL FILM PROCESSOR FPM2800 receive FDA 510(k) clearance?

FUJI MEDICAL FILM PROCESSOR FPM2800 received FDA 510(k) clearance on 1994-01-31, under 510(k) number K935957.

Who is the listed applicant for FUJI MEDICAL FILM PROCESSOR FPM2800?

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 MEDICAL FILM PROCESSOR FPM2800?

The FDA product code for FUJI MEDICAL FILM PROCESSOR FPM2800 is IXW.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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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: IXW)

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.

K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTVelopex International, Inc.K093503INTRAX FILM PROCESSORVelopex International, Inc.K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KGK024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.

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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