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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 K111865
Device Name WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
Applicant
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902 -6300
Applicant Contact DEBBIE PEACOCK
Correspondent
Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford,  CT  06902 -6300
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/30/2011
Decision Date 09/30/2011
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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