Class Class II
Neuro Insight V1.0 (K243681)
Description
Neuro Insight V1.0 by Olea Medical S.A.S., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243681
Clearance Date2025-07-23
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243681
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Neuro Insight V1.0 (K243681) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | 2023 |
| K152602 | Olea Sphere V3.0 | Olea Medical | 2016 |
Trace the full predicate network for K243681
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.