K153464

Substantially Equivalent

FDR D-EVO flat Panel Detector System

Applicant: Fujifilm Medical Systems U.S.A, Inc.
Product code: MQB
Advisory panel: Radiology
Date received: 2015-12-01
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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