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FDA 510(k)

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR

K-Number: K952862 · 1995-09-20

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1995-09-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR 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 1995-09-20 under 510(k) number K952862. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR?

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR is a medical device that received FDA 510(k) clearance on 1995-09-20. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K952862.

When did FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR receive FDA 510(k) clearance?

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR received FDA 510(k) clearance on 1995-09-20, under 510(k) number K952862.

Who is the listed applicant for FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR?

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 FCR9501ES.FCR?

The FDA product code for FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR is LLZ.

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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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