FCR GO PORTABLE DIGITAL X-RAY SYSTEM


Device Classification Name

system, x-ray, mobile

510(k) Number K080945
Device Name FCR GO PORTABLE DIGITAL X-RAY SYSTEM
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact debbie peacock
Regulation Number 892.1720
Classification Product Code
IZL  
Date Received 04/03/2008
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No