FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION


Device Classification Name

system, x-ray, stationary

510(k) Number K122454
Device Name FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
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
KPR  
Date Received 08/13/2012
Decision Date 11/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No