IGROK


Device Classification Name

system, image processing, radiological

510(k) Number K080325
Device Name IGROK
Applicant
IGROK, LLC
234 graham st., ste 200
sewickley, 
PA 
15143

Applicant Contact robert j riker
Correspondent
IGROK, LLC
234 graham st., ste 200
sewickley, 
PA 
15143

Correspodent Contact robert j riker
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/06/2008
Decision Date 04/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No