The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia Va10a Family.
| Device ID | K210557 |
| 510k Number | K210557 |
| Device Name: | Symbia VA10A Family |
| 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 | 2021-02-25 |
| Decision Date | 2021-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869264769 | K210557 | 000 |
| 04056869264752 | K210557 | 000 |
| 04056869264745 | K210557 | 000 |