Resonance Health Analysis Services Pty, Ltd.

Resonance Health Analysis Services Pty, Ltd. specializes in MRI-related devices, including MRI phantoms and test objects like the FerriSmart, R2*/T2* Phantom, and T1CMR Phantom for 1.5T and 3.0T systems. They also produce specialized phantoms such as FerriScan and HepaFat-Scan, which are designed for liver iron and fat quantification, as well as cardiac T2* analysis tools. Additionally, they offer MRI system application software, such as the MRI-Q SYSTEM and FERRISCAN R2-MRI ANALYSIS SYSTEM, which aids in diagnostic imaging analysis and calibration.

Resonance Health Analysis Services Pty, Ltd. is based in the United States, meaning its devices must comply with FDA regulations. Since the company’s products fall under Class I and Class II classifications, their regulatory submissions—such as 510(k) clearances and UDI registrations—are tracked in the FDA’s public databases. This ensures transparency and adherence to U.S. medical device authorization standards.

Devices from Resonance Health Analysis Services Pty, Ltd. appear in the FDA’s 510(k) and UDI databases. The 510(k) registry tracks premarket submissions for devices deemed to be substantially equivalent to existing authorized products, while the UDI system ensures unique identification and traceability of medical devices in the U.S. market. These listings reflect the company’s compliance with FDA requirements for device authorization.

Resonance Health Analysis Services Pty, Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require only general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and submission requirements, such as 510(k) clearances for Class II devices, ensuring appropriate oversight.

The application software products, like the MRI-Q SYSTEM and FERRISCAN R2-MRI ANALYSIS SYSTEM, are designed to support MRI diagnostics by automating analysis, calibration, and quantification tasks. For example, FerriScan and HepaFat-Scan software assist in measuring liver iron and fat content, while cardiac T2* analysis tools help evaluate tissue characteristics. These tools enhance diagnostic accuracy and efficiency by integrating directly with MRI systems.