Device Classification Name |
tomographic imager combining emission computed tomography with nuclear magnetic resonance
|
510(k) Number |
K163234 |
Device Name |
Biograph mMR with syngo MR E11P system software |
Applicant |
Siemens Medical Solutions USA, Inc. |
65 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Cordell L. Fields |
Correspondent |
Siemens Medical Solutions USA, Inc. |
65 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Correspondent Contact |
Cordell L. Fields |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/17/2016 |
Decision Date | 02/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|