K231384
- 510(k) number
- K231384
- Device name
- Annalise Enterprise CTB Triage Trauma
- Applicant
- Annalise-Ai Pty , Ltd. AU
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2023-09-22
- Date received
- 2023-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K231384.pdf
Official FDA record: K231384
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.