Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K130885 |
Device Name |
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
757 A ARNOLD DRIVE |
MARTINEZ,
CA
94553
|
|
Applicant Contact |
CHRISTINE DUNBAR |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
757 A ARNOLD DRIVE |
MARTINEZ,
CA
94553
|
|
Correspondent Contact |
CHRISTINE DUNBAR |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/29/2013 |
Decision Date | 05/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|