K260406
- 510(k) number
- K260406
- Device name
- Brainomix 360 Hyperdensity
- Applicant
- Brainomix Limited GB
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-12
- Date received
- 2026-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260406.pdf
Official FDA record: K260406
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.