K231897
- 510(k) number
- K231897
- Device name
- NeuroAlign software
- Applicant
- Medivis, Inc. NY · US
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-10-21
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231897.pdf
Official FDA record: K231897
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.