Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K123920 |
Device Name |
SYNGO.VIA |
Applicant |
SIEMENS AG, MEDICAL SOLUTIONS |
HENKESTRASSE 127 |
ERLANGEN,
DE
91052
|
|
Applicant Contact |
SABINE SCHROEDEL |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/20/2012 |
Decision Date | 01/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|