Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K162145 |
Device Name |
vRad PACS with Mammography |
Applicant |
Virtual Radiologic Corporation |
11995 Singletree Lane, Suite 500 |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Melinda Sewell |
Correspondent |
Virtual Radiologic Corporation |
11995 Singletree Lane, Suite 500 |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Melinda Sewell |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/01/2016 |
Decision Date | 10/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|