K232431
- 510(k) number
- K232431
- Device name
- syngo.CT Brain Hemorrhage
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2024-03-22
- Date received
- 2023-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232431.pdf
Official FDA record: K232431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.