THE IC-PRO SYSTEM


Device Classification Name

system, x-ray, angiographic

510(k) Number K110256
Device Name THE IC-PRO SYSTEM
Applicant
PAIEON, INC.
23 hamelacha st., p.o.b. 11355
rosh haayin, 

IL

48901

Applicant Contact erez ben-zvi
Correspondent
PAIEON, INC.
23 hamelacha st., p.o.b. 11355
rosh haayin, 

IL

48901

Correspodent Contact erez ben-zvi
Regulation Number 892.1600
Classification Product Code
IZI  
Subsequent Product Code
LLZ  
Date Received 01/28/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No