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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 K120629
Model DR-ID700 W/DR-ID601SE, DR-ID602SE, DR-ID611SE
Device Name FDR GO FLEX
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford,  CT  06902 6300
Contact peter altman
Regulation Number892.1650
Classification Product Code
MQB  
Date Received03/01/2012
Decision Date 08/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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