The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Horizon Pet/ct And Biograph Mct Pet/ct And Biograph Mct Flow Pet/ct.
Device ID | K162736 |
510k Number | K162736 |
Device Name: | Biograph Horizon PET/CT And Biograph MCT PET/CT And Biograph MCT Flow PET/CT |
Classification | System, Tomography, Computed, Emission |
Applicant | Siemens Medical Solutions USA, Inc. 810 INNOVATION DRIVE Knoxville, TN 37932 |
Contact | Alaine Medio |
Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 INNOVATION DRIVE Knoxville, TN 37932 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-30 |
Decision Date | 2016-10-25 |
Summary: | summary |