K253818
- 510(k) number
- K253818
- Device name
- Annalise Enterprise
- Applicant
- Harrison-AI Medical Pty, Ltd. AU
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2026-03-03
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253818.pdf
Official FDA record: K253818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.