Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K121447 |
Device Name |
ISCHEMA VIEW RAPID |
Applicant |
ISCHEMA VIEW, INC. |
5405 ALTON PARKWAY 5A, #530 |
IRVINE,
CA
92604
|
|
Applicant Contact |
MARC GOODMAN |
Correspondent |
ISCHEMA VIEW, INC. |
5405 ALTON PARKWAY 5A, #530 |
IRVINE,
CA
92604
|
|
Correspondent Contact |
MARC GOODMAN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/15/2012 |
Decision Date | 10/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|