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FDA 510(k)

GyriCalc (Version 1.0.0)

K-Number: K250686 · 2025-07-22

ApplicantNeurospectrum Insights Corp.
Decision Date2025-07-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GyriCalc (Version 1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Neurospectrum Insights Corp.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K250686. 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 GyriCalc (Version 1.0.0)?

GyriCalc (Version 1.0.0) is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Neurospectrum Insights Corp.. The 510(k) number is K250686.

When did GyriCalc (Version 1.0.0) receive FDA 510(k) clearance?

GyriCalc (Version 1.0.0) received FDA 510(k) clearance on 2025-07-22, under 510(k) number K250686.

Who is the listed applicant for GyriCalc (Version 1.0.0)?

The FDA 510(k) record lists Neurospectrum Insights Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GyriCalc (Version 1.0.0)?

The FDA product code for GyriCalc (Version 1.0.0) is LLZ.

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.

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Official Source

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

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