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FDA 510(k)

NeuroAlign software

K-Number: K231897 · 2025-10-21

ApplicantMedivis, Inc.
Decision Date2025-10-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroAlign software is a medical device manufactured by Medivis, Inc.. It received FDA 510(k) clearance on 2025-10-21 under approval number K231897. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroAlign software?

NeuroAlign software is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by Medivis, Inc.. The 510(k) number is K231897.

When was NeuroAlign software approved by the FDA?

NeuroAlign software received FDA 510(k) clearance on 2025-10-21, under approval number K231897.

What company makes NeuroAlign software?

NeuroAlign software is manufactured by Medivis, Inc..

What is the FDA product code for NeuroAlign software?

The FDA product code for NeuroAlign software is HAW.

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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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