NeuroAlign software— 510(k) K231897

Substantially Equivalent

Medivis, Inc.

FDA 510(k) clearance K231897 for NeuroAlign software, Substantially Equivalent on 2025-10-21. Applicant: Medivis, Inc..

Clearance details

Applicant: Medivis, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2023-06-28
Decision date: 2025-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.