The following data is part of a premarket notification filed by Siemens Medical Solution Usa, Inc. with the FDA for Biograph Horizon.
| Device ID | K193178 |
| 510k Number | K193178 |
| Device Name: | Biograph Horizon |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Siemens Medical Solution USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio Siemens Medical Solution 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 | 2019-11-18 |
| Decision Date | 2020-02-12 |