HepaFat-Scan
GUDID 09355529000040
Standalone software application to facilitate the import and visualization of multi slice, gradient echo MRI data sets encompassing the abdomen, with functionality independent of the MRI equipment, to provide objective and reproducible determination of the triglyceride fat fraction in magnetic resonance images of the liver. 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. HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. 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.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
MRI system application software| Primary Device ID | 09355529000040 |
| NIH Device Record Key | 480091d2-e603-4bbd-9e27-b466f8e8d8f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HepaFat-Scan |
| Version Model Number | V1.1.0 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com | |
| Phone | +61892865300 |
| support@resonancehealth.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09355529000040 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122035
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 | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
| 09369998038619 - FerriSmart | 2024-06-17 FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing t |
| 09355529000057 - FerriSmart | 2024-06-14 FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (L |
| 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 |
Trademark Results [HepaFat-Scan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEPAFAT-SCAN 79160958 4872442 Live/Registered |
Resonance Health Analysis Services Pty Ltd 2014-05-26 |
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