syngo.CT Brain Hemorrhage is an AI-enabled medical device from Siemens Medical Solutions USA, Inc., listed by FDA (510(k), K203260) with a decision date of 2022-01-28. Review panel: Radiology.
| FDA submission number | K203260 |
|---|---|
| Pathway | 510(k) |
| Company | Siemens Medical Solutions USA, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-01-28 |
| Decision | Substantially Equivalent |
| Product code | QAS |
| Classification | Radiological Computer-Assisted Triage And Notification Software |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 449 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.