← Back to catalogue

LiverSmart

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213776

by Resonance Health Analysis Services Pty, Ltd.

Identifiers

510(k) Number
K213776 FDA 510(k)
FDA Product Code
PCS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1001 FDA 510(k)
Regulation Number
892.1001 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LiverSmart is a Liver Iron Concentration Imaging Companion Diagnostic designed to quantify hepatic iron concentration via MRI analysis. It supports clinical decision-making for patients undergoing treatment with deferasirox by providing precise iron load measurements, aiding in the assessment of iron overload disorders such as hemochromatosis or thalassemia.

This device is intended for use in radiology settings and is supplied as a software-based solution integrated with MRI systems. It is classified as a Class II device under FDA regulations (21 CFR 892.1001) and has received FDA 510(k) clearance (K213776) as substantially equivalent to a predicate device. No sterility or single-use/reusable designation is specified, and MRI safety compliance is implied through its integration with MRI-compatible systems.

Frequently asked questions

What clinical conditions is the LiverSmart designed to help assess in patients?

The LiverSmart is specifically designed to quantify hepatic iron concentration via MRI analysis, aiding in the clinical assessment of iron overload disorders such as hemochromatosis or thalassemia. It supports decision-making for patients undergoing treatment with deferasirox by providing precise iron load measurements, helping clinicians monitor and manage iron overload effectively.

How is the LiverSmart supplied and where would it be used in a healthcare setting?

The LiverSmart is supplied as a software-based solution that integrates directly with MRI systems. It is intended for use exclusively in radiology settings, where it assists radiologists or clinicians in analyzing MRI scans to determine hepatic iron concentration.

Is the LiverSmart a single-use or reusable device, and what are its sterility requirements?

The LiverSmart is not designated as single-use or reusable in its specifications, meaning it is intended for repeated use within its operational lifecycle. Since it is a software-based solution integrated with MRI systems, sterility requirements do not apply as they would for physical medical devices.

What regulatory pathway was followed for the FDA clearance of the LiverSmart?

The LiverSmart received FDA 510(k) clearance under a special review pathway, classified as substantially equivalent to a predicate device. The clearance was granted under the product code PCS (Postmarket Clinical Studies) and falls under the regulatory category 21 CFR 892.1001, which pertains to Class II devices in radiology. The submission was reviewed by the Radiology (RA) Advisory Committee.

Does the LiverSmart require any special handling or storage conditions?

As a software-based solution integrated with MRI systems, the LiverSmart does not have specific physical storage requirements like traditional medical devices. However, it must be used in compliance with MRI safety standards, as it is designed to operate within MRI-compatible environments. Ensure the MRI system it integrates with meets all necessary safety and operational guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MRI Solutions for Liver & Heart Iron Assessment | Resonance Health, Leading Medical Imaging Analysis Solutions | Resonance Health, Resonance Health Analysis Services Pty, Ltd. 510(k) Products 2023

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Resonance Health Analysis Services Pty, Ltd.

Sources (1)

  • FDA 510(k) K213776 24 fields · synced Sep 19, 2026