Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K173578 |
Device Name |
Biograph mCT Family of PET/CT Systems |
Applicant |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Applicant Contact |
Tabitha Estes |
Correspondent |
Siemens Medical Solutions USA, Inc. |
810 Innovation Drive |
Knoxville,
TN
37932
|
|
Correspondent Contact |
Tabitha Estes |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/20/2017 |
Decision Date | 12/20/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|