Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K113027 |
Device Name |
SYNGO AORTIC VALVEGUIDE SOFTWARE |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
PATRICIA D JONES |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
PATRICIA D JONES |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/11/2011 |
Decision Date | 11/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|