K233968
- 510(k) number
- K233968
- Device name
- CINA-iPE
- Applicant
- Avicenna.Ai FR
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2024-03-13
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233968.pdf
Official FDA record: K233968
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.