The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia 6.7.
| Device ID | K200474 |
| 510k Number | K200474 |
| Device Name: | Symbia 6.7 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 -2061 |
| Contact | Cynthia Busch |
| Correspondent | Cynthia Busch Siemens Medical Solutions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 -2061 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-26 |
| Decision Date | 2020-03-20 |