K234141
- 510(k) number
- K234141
- Device name
- AISAP Cardio V1.0
- Applicant
- Aisap IL
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-08-01
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K234141.pdf
Official FDA record: K234141
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.