K243681
- 510(k) number
- K243681
- Device name
- Neuro Insight V1.0
- Applicant
- Olea Medical S.A.S. FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-07-23
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243681.pdf
Official FDA record: K243681
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.