Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K133435 |
Device Name |
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
NADIA SOOKDEO |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
NADIA SOOKDEO |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/08/2013 |
Decision Date | 12/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|