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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K153464
Device Name FDR D-EVO flat Panel Detector System
Applicant
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact Katherine Y. Choi
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact Peter Altman
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/01/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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