The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia T16, Symbia Intevo 16 And Symbia Intevo Bold.
| Device ID | K173023 |
| 510k Number | K173023 |
| Device Name: | Symbia T16, Symbia Intevo 16 And Symbia Intevo Bold |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
| Contact | Tabitha Estes |
| Correspondent | Tabitha Estes Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-11-17 |
| Summary: | summary |