Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K170221 |
Device Name |
syngo.CT Cardiac Planning |
Applicant |
Siemens Healthcare GmbH |
Siemensstr. 1 |
Forchheim,
DE
91301
|
|
Applicant Contact |
Martin Knoppik |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
George Bauer |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 01/25/2017 |
Decision Date | 04/21/2017 |
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
|
|
|