The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.ct Neuro Perfusion.
| Device ID | K202213 |
| 510k Number | K202213 |
| Device Name: | Syngo.CT Neuro Perfusion |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 2501 N. Barrington Rd. Hoffman Estates, IL 60192 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Solutions USA, Inc. 2501 N. Barrington Rd. Hoffman Estates, IL 60192 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2020-10-11 |