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
|
|
Correspondent Contact |
JASJIT S SURI |
Regulation Number | 892.2050
|
Classification Product Code |
|
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
|
|
|