WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE


Device Classification Name

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

510(k) Number K111548
Device Name WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact katherine y choi
Correspondent
FUJIFILM MEDICAL SYSTEM 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 06/03/2011
Decision Date 08/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No