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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
Device Name FDR GO FLEX
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Applicant Contact PETER ALTMAN
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Correspondent Contact PETER ALTMAN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/01/2012
Decision Date 08/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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