K233342
- 510(k) number
- K233342
- Device name
- CINA-ASPECTS
- Applicant
- Avicenna.Ai FR
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-03-15
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233342.pdf
Official FDA record: K233342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.