K233108
- 510(k) number
- K233108
- Device name
- VinDr-Mammo
- Applicant
- Vinbigdata Joint Stock Company VN
- Product code
- QFM — Radiological Computer-Assisted Prioritization Softwa
- Decision date
- 2024-05-23
- Date received
- 2023-09-27
- 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: K233108.pdf
Official FDA record: K233108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.