K240680
- 510(k) number
- K240680
- Device name
- CDM Insights
- Applicant
- Oxford Brain Diagnostics, Ltd. GB
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-12-06
- Date received
- 2024-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K240680.pdf
Official FDA record: K240680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.