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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 the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical S.A.S.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) 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. The listed applicant is Olea Medical S.A.S.. The 510(k) number is K243681.

When did Neuro Insight V1.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuro Insight V1.0?

The FDA 510(k) record lists Olea Medical S.A.S. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Olea Medical S.A.S. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243680Neurovascular Insight V1.0K221426Functional MR V1.0

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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