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FDA 510(k)

FDR D-EVO flat Panel Detector System

K-Number: K153464 · 2016-04-08

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2016-04-08
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR D-EVO flat Panel Detector System is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-04-08 under approval number K153464. 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 flat Panel Detector System?

FDR D-EVO flat Panel Detector System is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K153464.

When was FDR D-EVO flat Panel Detector System approved by the FDA?

FDR D-EVO flat Panel Detector System received FDA 510(k) clearance on 2016-04-08, under approval number K153464.

What company makes FDR D-EVO flat Panel Detector System?

FDR D-EVO flat Panel Detector System is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for FDR D-EVO flat Panel Detector System?

The FDA product code for FDR D-EVO flat Panel Detector System is MQB.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39382899 US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement. JAMA network open (2024) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016) PMID: 27847262 The AngelMed Guardian system: Is there a role for implantable devices for early detection of coronary artery occlusion? Cardiovascular revascularization medicine : including molecular interventions (2016) PMID: 25499024 Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Cardiovascular revascularization medicine : including molecular interventions (2014)

Other Devices by Fujifilm Medical Systems U.S.A, Inc.

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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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