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FDA 510(k)

FDR GO FLEX

K-Number: K120629 · 2012-08-28

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2012-08-28
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR GO FLEX 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 2012-08-28 under 510(k) number K120629. 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 FDR GO FLEX?

FDR GO FLEX is a medical device that received FDA 510(k) clearance on 2012-08-28. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K120629.

When did FDR GO FLEX receive FDA 510(k) clearance?

FDR GO FLEX received FDA 510(k) clearance on 2012-08-28, under 510(k) number K120629.

Who is the listed applicant for FDR GO FLEX?

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 FDR GO FLEX?

The FDA product code for FDR GO FLEX is MQB.

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

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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