HepaFat-AI is an AI-enabled medical device from Resonance Health Analysis Services Pty Ltd, listed by FDA (510(k), K201039) with a decision date of 2020-12-07. Review panel: Radiology.
| FDA submission number | K201039 |
|---|---|
| Pathway | 510(k) |
| Company | Resonance Health Analysis Services Pty Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2020-12-07 |
| Decision | Substantially Equivalent |
| Product code | LNH |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Device class | 2 |
| Regulation number | 892.1000 |
| Review time (calendar days) | 231 |
| Applicant country | AU |
Official FDA database record · FDA AI-enabled device list
More devices from Resonance Health Analysis Services Pty Ltd · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.