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 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 MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software
Primary Device ID09355529000002
NIH Device Record Keyc0a7b8f1-a95b-479e-84f6-ddc7a71a4758
Commercial Distribution StatusIn Commercial Distribution
Brand NameFerriScan, Cardiac T2*
Version Model Number4.0.0
Company DUNS740449913
Company NameRESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com
Phone+61892865300
Emailsupport@resonancehealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109355529000002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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 Phantom2024-04-25 Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of n
09355529000088 - R2*/T2* Phantom2024-04-25 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 Phantom2024-04-18 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*2023-06-27Software 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.
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-AI2023-06-26 Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to gener
09355529000040 - HepaFat-Scan2023-06-26 Standalone software application to facilitate the import and visualization of multi slice, gradient echo MRI data sets encompass

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.