The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo.ct Skull Unfolding.
| Device ID | K203411 |
| 510k Number | K203411 |
| Device Name: | Syngo.CT Skull Unfolding |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869267463 | K203411 | 000 |