FerriSmart -

GUDID 09355529000057

FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically. It automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients. The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management. FerriSmart is indicated to: • Support clinical diagnoses in individuals with confirmed or suspected liver iron overload; • Assessment of liver iron loading to support the subsequent clinical decision-making for patients under management of diseases such as thalassaemia disorders or hereditary haemochromatosis. • Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver iron concentration, the subsequent clinical decision-making processes for the management of iron overload diseases.

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

MRI system application software

• Primary Device ID: 09355529000057
• NIH Device Record Key: e684dbaf-4248-4073-a9a4-ddcb291475af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FerriSmart
• Version Model Number: v2.2.4
• Catalog Number: -
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09355529000057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182218

FDA Product Code

• PCS: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

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: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [FerriSmart]

• 09355529000057: FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2
• 09369998038619: FerriSmart is a stand-alone software application that automatically analyses multi slice, spin e