The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Syngo.ct Applications.
| Device ID | K220450 |
| 510k Number | K220450 |
| Device Name: | Syngo.CT Applications |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Clayton Ginn |
| Correspondent | Clayton Ginn Siemens Medical Solutions USA Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869287416 | K220450 | 000 |