FDA 510(k)

NeuroAlign software

K-Number: K231897 · 2025-10-21

Decision Date2025-10-21

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeuroAlign software is the device name listed in this FDA 510(k) record. The listed applicant is Medivis, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) 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. The listed applicant is Medivis, Inc.. The 510(k) number is K231897.

When did NeuroAlign software receive FDA 510(k) clearance?

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

Who is the listed applicant for NeuroAlign software?

The FDA 510(k) record lists Medivis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroAlign software?

The FDA product code for NeuroAlign software is HAW.

Other records listing Medivis, Inc. as applicant

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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.