Cleared Traditional

NeuroAlign software

K231897 · Medivis, Inc. · Neurology
Oct 2025
Decision
846d
Days
Class 2
Risk

About This 510(k) Submission

K231897 is an FDA 510(k) clearance for the NeuroAlign software, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Medivis, Inc. (New York, US). The FDA issued a Cleared decision on October 21, 2025, 846 days after receiving the submission on June 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K231897 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date October 21, 2025
Days to Decision 846 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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