IMIX INSIGHT X-RAY SYSTEMS


Device Classification Name

system, x-ray, stationary

510(k) Number K073114
Device Name IMIX INSIGHT X-RAY SYSTEMS
Applicant
IMIX ADR FINLAND OY
p.o. box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
IMIX ADR FINLAND OY
p.o. box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 11/05/2007
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No