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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 K152138
Device Name FDR D-EVO GL Flat Panel Detector System
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Applicant Contact Katherine Y Choi
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Correspondent Contact Katherine Y Choi
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/31/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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