Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K141302 |
Device Name |
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) |
Applicant |
VITAL IMAGES, INC. |
5850 Opus Pkwy Ste 300 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
PARTHIV SHAH |
Correspondent |
VITAL IMAGES, INC. |
5850 Opus Pkwy Ste 300 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
PARTHIV SHAH |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/19/2014 |
Decision Date | 08/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|