Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K182299 |
Device Name |
MAGNETOM Aera |
Applicant |
Siemens Medical Solutions USA Inc. |
40 Liberty Boulevard, Mail Code 65-IA |
Malvern,
PA
19355
|
|
Applicant Contact |
Martin Rajchel |
Correspondent |
Siemens Medical Solutions USA Inc. |
40 Liberty Boulevard, Mail Code 65-IA |
Malvern,
PA
19355
|
|
Correspondent Contact |
Martin Rajchel |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/24/2018 |
Decision Date | 10/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|