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FDA 510(k)

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ

K-Number: K951373 · 1995-10-27

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1995-10-27
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ 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 1995-10-27 under 510(k) number K951373. 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 COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ?

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K951373.

When did FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ received FDA 510(k) clearance on 1995-10-27, under 510(k) number K951373.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ?

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 COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ?

The FDA product code for FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ is IXW.

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

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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.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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