Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K163232 |
Device Name |
Vitrea View |
Applicant |
Vital Images, Inc |
5850 Opus Parkway |
Suite 300 |
minnetonka,
MN
55343
|
|
Applicant Contact |
fei li |
Correspondent |
Vital Images, Inc |
5850 Opus Parkway |
Suite 300 |
minnetonka,
MN
55343
|
|
Correspondent Contact |
fei li |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/17/2016 |
Decision Date | 07/21/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|