K243680
- 510(k) number
- K243680
- Device name
- Neurovascular Insight V1.0
- Applicant
- Olea Medical S.A.S. FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-25
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243680.pdf
Official FDA record: K243680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.