HepaFatSmart -
GUDID 09355529000095
Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver. When interpreted by a trained physician, the results provide information that can aid in diagnosis. HepaFatSmart is indicated to: • Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; • Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis. • Support the subsequent clinical decision-making processes for patients Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software| Primary Device ID | 09355529000095 |
| NIH Device Record Key | c3f1989b-34cd-4c23-8dbd-25122c0f6c0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HepaFatSmart |
| Version Model Number | v2.0.0 |
| 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 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com | |
| Phone | +61892865300 |
| quality@resonancehealth.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09355529000095 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231459
FDA Product Code
| LNH | System, Nuclear Magnetic Resonance Imaging |
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 | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
| 09355529000095 - HepaFatSmart | 2024-05-07Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver. When interpreted by a trained physician, the results provide information that can aid in diagnosis. HepaFatSmart is indicated to: • Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; • Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis. • Support the subsequent clinical decision-making processes for patients Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases. |
| 09355529000095 - HepaFatSmart | 2024-05-07 Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) d |
| 09355529000033 - T1CMR Phantom (1.5T) | 2024-04-25 The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement i |
| 09355529000064 - T1CMR Phantom (3.0T) | 2024-04-25 The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement i |
| 09355529000071 - T2CMR Phantom | 2024-04-25 Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of n |
| 09355529000088 - R2*/T2* Phantom | 2024-04-25 The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential |
| 09355529000026 - FerriScan Phantom | 2024-04-18 Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydr |
| 09355529000002 - FerriScan, Cardiac T2* | 2023-06-27 Software tool to facilitate the import and visualization of multi slice, spin echo MRI data sets encompassing the liver and card |
| 09355529000019 - HepaFat-AI | 2023-06-26 Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to gener |
Trademark Results [HepaFatSmart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEPAFATSMART 79379758 not registered Live/Pending |
Resonance Health Analysis Services Pty Ltd 2023-08-17 |
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