The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc with the FDA for Biograph Vision, Biograph Mct Family Of Pet/cts.
| Device ID | K193248 |
| 510k Number | K193248 |
| Device Name: | Biograph Vision, Biograph MCT Family Of PET/CTs |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Siemens Medical Solutions USA, Inc 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Tabitha Estes |
| Correspondent | Tabitha Estes 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 | 2019-11-25 |
| Decision Date | 2020-02-14 |