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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 a medical device manufactured by Neurospectrum Insights Corp.. It received FDA 510(k) clearance on 2025-07-22 under approval 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. It is manufactured by Neurospectrum Insights Corp.. The 510(k) number is K250686.

When was GyriCalc (Version 1.0.0) approved by the FDA?

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

What company makes GyriCalc (Version 1.0.0)?

GyriCalc (Version 1.0.0) is manufactured by Neurospectrum Insights Corp..

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

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

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Official Source

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