LiverSmart is an AI-enabled medical device from Resonance Health Analysis Services Pty Ltd, listed by FDA (510(k), K213776) with a decision date of 2021-12-29. Review panel: Radiology.
| FDA submission number | K213776 |
|---|---|
| Pathway | 510(k) |
| Company | Resonance Health Analysis Services Pty Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-12-29 |
| Decision | Substantially Equivalent |
| Product code | PCS |
| Classification | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Device class | 2 |
| Regulation number | 892.1001 |
| Review time (calendar days) | 27 |
| Applicant country | AU |
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.