FerriScan, Cardiac T2*

GUDID 09355529000002

Software tool to facilitate the import and visualization of multi slice, spin echo MRI data sets encompassing the liver and cardiac tissue, with functionality independent of the MRI equipment vendor. The operational principle is based on fitting signal decay curves to the image signal intensities at the different echo times for the MR data set on a voxel by voxel (3 D pixel) basis to determine transverse relaxation rate (R2) images, that may be further transformed by a defined calibration to provide a quantitative measure of liver iron concentrations in vivo and fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel by voxel (3 D pixel) basis to determine the signal decay rate (R2*) and time (T2*) The obtained results can be used for the following purposes: 1. Supporting clinical diagnoses about the status of liver iron concentration and cardiac iron. 2. Supporting the subsequent clinical decision making processes. 3. Supporting the use in clinical research trials, directed at studying changes in liver iron concentration as a result of interventions. 4. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing images and performing region of interest analysis.

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

MRI system application software

• Primary Device ID: 09355529000002
• NIH Device Record Key: c0a7b8f1-a95b-479e-84f6-ddc7a71a4758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FerriScan, Cardiac T2*
• Version Model Number: 4.0.0
• Company DUNS: 740449913
• Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com
• Phone: +61892865300
• Email: support@resonancehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09355529000002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043271

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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