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FDA 510(k)

Neuro Insight V1.0

K-Number: K243681 · 2025-07-23

ApplicantOlea Medical S.A.S.
Decision Date2025-07-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neuro Insight V1.0 is a medical device manufactured by Olea Medical S.A.S.. It received FDA 510(k) clearance on 2025-07-23 under approval number K243681. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro Insight V1.0?

Neuro Insight V1.0 is a medical device that received FDA 510(k) clearance on 2025-07-23. It is manufactured by Olea Medical S.A.S.. The 510(k) number is K243681.

When was Neuro Insight V1.0 approved by the FDA?

Neuro Insight V1.0 received FDA 510(k) clearance on 2025-07-23, under approval number K243681.

What company makes Neuro Insight V1.0?

Neuro Insight V1.0 is manufactured by Olea Medical S.A.S..

What is the FDA product code for Neuro Insight V1.0?

The FDA product code for Neuro Insight V1.0 is LLZ.

Other Devices by Olea Medical S.A.S.

K221426Functional MR V1.0 K243680Neurovascular Insight V1.0

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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