Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K173897 |
Device Name |
syngo.via MI Workflows |
Applicant |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Applicant Contact |
Veronica Padharia |
Correspondent |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Correspondent Contact |
Veronica Padharia |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/22/2017 |
Decision Date | 04/05/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|