Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K162736 |
Device Name |
Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT |
Applicant |
Siemens Medical Solutions USA, Inc. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932
|
|
Applicant Contact |
ALAINE MEDIO |
Correspondent |
Siemens Medical Solutions USA, Inc. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932
|
|
Correspondent Contact |
ALAINE MEDIO |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 10/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|