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FDA 510(k)

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE

K-Number: K924012 · 1992-10-16

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1992-10-16
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE 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 1992-10-16 under 510(k) number K924012. 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 RADIOGRAPHY HI-C653 DMS CRT IMAGE?

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE is a medical device that received FDA 510(k) clearance on 1992-10-16. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K924012.

When did FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE received FDA 510(k) clearance on 1992-10-16, under 510(k) number K924012.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE?

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 HI-C653 DMS CRT IMAGE?

The FDA product code for FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE is IXK.

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

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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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