FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371


Device Classification Name

system, x-ray, stationary

510(k) Number K073650
Device Name FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
Applicant
FUJIFILM MEDICAL SYSTEMS USA, INC.
p.o. box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
FUJIFILM MEDICAL SYSTEMS USA, INC.
p.o. box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received 12/26/2007
Decision Date 02/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No