The following data is part of a premarket notification filed by Siemens Medical Soultions Usa, Inc. with the FDA for Syngo.ct Cardiac Planning.
| Device ID | K200515 |
| 510k Number | K200515 |
| Device Name: | Syngo.CT Cardiac Planning |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Soultions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Soultions USA, Inc. 2501 N Barrington Road Hoffman Estates, IL 60192 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-03-25 |