K243294
- 510(k) number
- K243294
- Device name
- Brainomix 360 e-ASPECTS
- Applicant
- Brainomix Limited GB
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2025-02-14
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243294.pdf
Official FDA record: K243294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.