Clarius Prostate AI is an AI-enabled medical device from Clarius Mobile Health Corp., listed by FDA (510(k), K243853) with a decision date of 2025-04-16. Review panel: Radiology.
| FDA submission number | K243853 |
|---|---|
| Pathway | 510(k) |
| Company | Clarius Mobile Health Corp. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-04-16 |
| Decision | Substantially Equivalent |
| Product code | QIH |
| Classification | Automated Radiological Image Processing Software |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 121 |
| Applicant country | CA |
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.