KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0


Device Classification Name

system, image processing, radiological

510(k) Number K051127
Device Name KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
Applicant
KIKA MEDICAL INC.
555 thirteenth street, nw.
washington, 
DC 
20004

Applicant Contact howard hostein
Correspondent
KIKA MEDICAL INC.
555 thirteenth street, nw.
washington, 
DC 
20004

Correspodent Contact howard hostein
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/03/2005
Decision Date 06/03/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No