ClearPoint System (Software Version 3.0) is an AI-enabled medical device from ClearPoint Neuro, Inc., listed by FDA (510(k), K243657) with a decision date of 2025-01-24. Review panel: Neurology.
| FDA submission number | K243657 |
|---|---|
| Pathway | 510(k) |
| Company | ClearPoint Neuro, Inc. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-01-24 |
| Decision | Substantially Equivalent |
| Product code | HAW |
| Classification | Neurological Stereotaxic Instrument |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 58 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.