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FDA 510(k)

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS

K-Number: K931002 · 1993-06-08

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1993-06-08
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS 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 1993-06-08 under 510(k) number K931002. The device is classified under product code IXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS?

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS is a medical device that received FDA 510(k) clearance on 1993-06-08. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K931002.

When did FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS received FDA 510(k) clearance on 1993-06-08, under 510(k) number K931002.

Who is the listed applicant for FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS?

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 RADIOGRAP HI-C654 DMS CRT IMAGE CONS?

The FDA product code for FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS is IXK.

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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: IXK)

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.

K093640DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.K072766PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision MedicalK042779RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.K032654PORT CASSETTEOrex Computed Radiography, Ltd.K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOAgfa Corp.

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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