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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 WEST AVE.
STAMFORD,  CT  06902 -6300
Applicant Contact DEBBIE PEACOCK
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST 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
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