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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) 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. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K153464.

When did FDR D-EVO flat Panel Detector System receive FDA 510(k) clearance?

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

Who is the listed applicant for FDR D-EVO flat Panel Detector System?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: MQB)

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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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