FUJIFILM FCR VIEW, MODEL CR-VW674


Device Classification Name

system, image processing, radiological

510(k) Number K081308
Device Name FUJIFILM FCR VIEW, MODEL CR-VW674
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Applicant Contact debra a peacock
Correspondent
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
419 west ave.
stamford, 
CT 
06902 -6300

Correspodent Contact debra a peacock
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/09/2008
Decision Date 06/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No