WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE


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

Correspodent Contact debbie peacock
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 06/30/2011
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