ATHEROEDGE


Device Classification Name

system, image processing, radiological

510(k) Number K122022
Device Name ATHEROEDGE
Applicant
ATHEROPOINT LLC
208 otter glen ct
roseville, 
CA 
95661

Applicant Contact jasjit s suri
Correspondent
ATHEROPOINT LLC
208 otter glen ct
roseville, 
CA 
95661

Correspodent Contact jasjit s suri
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/10/2012
Decision Date 09/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No