Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K093612 |
Device Name |
SYNGO.PLAZA |
Applicant |
SIEMENS AG, MEDICAL SOLUTIONS |
HENKESTRASSE 127 |
ERLANGEN,
DE
91052
|
|
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/23/2009 |
Decision Date | 03/04/2010 |
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
|
|
|