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FDA 510(k)

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

K-Number: K042023 · 2004-08-25

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2004-08-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER 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 2004-08-25 under 510(k) number K042023. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER?

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K042023.

When did FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER received FDA 510(k) clearance on 2004-08-25, under 510(k) number K042023.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER?

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 (FCR) CLEARVIEW CS IMAGE READER?

The FDA product code for FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER is MQB.

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

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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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