K251527
- 510(k) number
- K251527
- Device name
- Brain WMH
- Applicant
- Quantib B.V. NL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-09-25
- Date received
- 2025-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251527.pdf
Official FDA record: K251527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.