Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K110366 |
Device Name |
SYNGO.CT CARDIAC FUNCTION |
Applicant |
SIEMENS AG |
51 VALLEY STREAM PKWY |
MALVERN,
PA
19355
|
|
Applicant Contact |
RALF HOFFMANN |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
NORBERT STUIBER |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/07/2011 |
Decision Date | 04/12/2011 |
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
|
|
|