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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 K100762
Device Name FLAT PANEL DETECTOR, MODEL FDR D-EVO
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Applicant Contact DEBBIE PEACOCK
Correspondent
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/17/2010
Decision Date 07/15/2010
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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