Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K122136 |
Device Name |
VITREAVIEW |
Applicant |
VITAL IMAGES, INC. |
5850 Opus Pkwy Ste 300 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
Ian Nemerov |
Correspondent |
VITAL IMAGES, INC. |
5850 Opus Pkwy Ste 300 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
Ian Nemerov |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 09/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|