Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K101347 |
Device Name |
MAGNETOM AERA; MAGNETOM SKYRA |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA INC. |
53 VALLEY STREAM PARKWAY |
MALVERN,
PA
19533
|
|
Applicant Contact |
KIM RENDON |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA INC. |
53 VALLEY STREAM PARKWAY |
MALVERN,
PA
19533
|
|
Correspondent Contact |
KIM RENDON |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 05/13/2010 |
Decision Date | 10/01/2010 |
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
|
|
|