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FDA 510(k)

Neuralytix iD3 System (NTX-9001)

K-Number: K243636 · 2025-06-26

ApplicantNeuralytix, LLC
Decision Date2025-06-26
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Neuralytix iD3 System (NTX-9001) is a medical device manufactured by Neuralytix, LLC. It received FDA 510(k) clearance on 2025-06-26 under approval number K243636. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuralytix iD3 System (NTX-9001)?

Neuralytix iD3 System (NTX-9001) is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Neuralytix, LLC. The 510(k) number is K243636.

When was Neuralytix iD3 System (NTX-9001) approved by the FDA?

Neuralytix iD3 System (NTX-9001) received FDA 510(k) clearance on 2025-06-26, under approval number K243636.

What company makes Neuralytix iD3 System (NTX-9001)?

Neuralytix iD3 System (NTX-9001) is manufactured by Neuralytix, LLC.

What is the FDA product code for Neuralytix iD3 System (NTX-9001)?

The FDA product code for Neuralytix iD3 System (NTX-9001) is PDQ.

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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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