Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K132532 |
Device Name |
SYNGO.PLAZA VB10A |
Applicant |
SIEMENS AG HEALTHCARE |
HENKESTRASSE 127 |
erlangen,
DE
91052
|
|
Applicant Contact |
viktoria benz |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
new brighton,
MN
55112 -1891
|
|
Correspondent Contact |
norbert stuiber |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/12/2013 |
Decision Date | 12/09/2013 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|