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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 a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-11-12 under approval 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. It is manufactured by Fujifilm Corporation. The 510(k) number is K192932.

When was FDR D-EVO III flat panel detector system approved by the FDA?

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

What company makes FDR D-EVO III flat panel detector system?

FDR D-EVO III flat panel detector system is manufactured by Fujifilm Corporation.

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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Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, 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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