Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K143079 |
Device Name |
Endovascular Stent Planning Software |
Applicant |
VITAL IMAGES, INC. |
5850 OPUS PARKWAY, |
SUITE 300 |
MINNETONKA,
MN
55343 -4414
|
|
Applicant Contact |
Parthiv Shah |
Correspondent |
VITAL IMAGES, INC. |
5850 OPUS PARKWAY, |
SUITE 300 |
MINNETONKA,
MN
55343 -4414
|
|
Correspondent Contact |
Parthiv Shah |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/27/2014 |
Decision Date | 12/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|