Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K070322 |
Device Name |
SYNGO DYNAMICS, VERSION 6.0 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
400 W. MORGAN ROAD |
SUITE 100 |
ANN ARBOR,
MI
48108 -9117
|
|
Applicant Contact |
SIEGLINDE NINA WEST |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 02/02/2007 |
Decision Date | 02/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|