K231025
- 510(k) number
- K231025
- Device name
- EFAI NeuroSuite CT ICH Assessment System
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2023-10-04
- Date received
- 2023-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231025.pdf
Official FDA record: K231025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.