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FDA 510(k)

FDR D-EVO III flat panel detector system

K-Number: K192932 · 2019-11-12

ApplicantFujifilm Corporation
Decision Date2019-11-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR D-EVO III flat panel detector system is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192932. 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 D-EVO III flat panel detector system?

FDR D-EVO III flat panel detector system is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Fujifilm Corporation. The 510(k) number is K192932.

When did FDR D-EVO III flat panel detector system receive FDA 510(k) clearance?

FDR D-EVO III flat panel detector system received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192932.

Who is the listed applicant for FDR D-EVO III flat panel detector system?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FDR D-EVO III flat panel detector system?

The FDA product code for FDR D-EVO III flat panel detector system is MQB.

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Other records listing Fujifilm Corporation 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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