LiverSmart is an AI-enabled medical device from Resonance Health Analysis Services Pty Ltd that the U.S. FDA cleared through 510(k) K213776 on December 29, 2021. Its lead review panel is Radiology and its primary product code is PCS (Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox).
See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.
Key facts
| Submission number | K213776 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Resonance Health Analysis Services Pty Ltd |
| Lead review panel | Radiology |
| Primary product code | PCS — Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Applicant (openFDA) | Resonance Health Analysis Services Pty, Ltd. |
| Applicant location | Perth, AU |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1001 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. LiverSmart went through this pathway (K213776).
openFDA lists it as a Class 2 device under 21 CFR 892.1001. Class II devices are moderate risk and are subject to general and special controls.
Product code PCS covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Resonance Health Analysis Services Pty Ltd has 4 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.