WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K103596
Device Name WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact katherine y choi
Correspondent
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Correspodent Contact katherine y choi
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 12/08/2010
Decision Date 03/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No