The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc with the FDA for Syngo.ct Dual Energy.
| Device ID | K191468 |
| 510k Number | K191468 |
| Device Name: | Syngo.CT Dual Energy |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions, USA, Inc 2501 N. Barrington Road Hoffman Estates, IL 60192 |
| Contact | Cynthia Busch |
| Correspondent | Cynthia Busch Siemens Medical Solutions, 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 | 2019-06-03 |
| Decision Date | 2019-07-03 |