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FDA 510(k)

FUJI FCR IMAGE PROCESSING UNIT IP-U515

K-Number: K942561 · 1994-12-23

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1994-12-23
Product CodeIXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI FCR IMAGE PROCESSING UNIT IP-U515 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 1994-12-23 under 510(k) number K942561. 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 FCR IMAGE PROCESSING UNIT IP-U515?

FUJI FCR IMAGE PROCESSING UNIT IP-U515 is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K942561.

When did FUJI FCR IMAGE PROCESSING UNIT IP-U515 receive FDA 510(k) clearance?

FUJI FCR IMAGE PROCESSING UNIT IP-U515 received FDA 510(k) clearance on 1994-12-23, under 510(k) number K942561.

Who is the listed applicant for FUJI FCR IMAGE PROCESSING UNIT IP-U515?

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 FCR IMAGE PROCESSING UNIT IP-U515?

The FDA product code for FUJI FCR IMAGE PROCESSING UNIT IP-U515 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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