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FDA-cleared K243681

Neuro Insight V1.0

Olea Medical S.A.S.

Authorized purpose: Neuro Insight V1.0 assists trained professionals analyzing neurological MRI through NeuroPro maps/metrics and optional Neuro Synchronizer viewing, comparison, and parameter editing in compatible DICOM integration environments; it does not alter original images or replace diagnosis.

Modality
MRI
Anatomy
Brain
Decision
2025-07-23