FerriScan, Cardiac T2*

Primary DI
09355529000002
Brand
FerriScan, Cardiac T2*
Company
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Model
4.0.0
Device description
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.
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043271000
K111222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043271000R2-MRI ANALYSIS SYSTEMInner Vision Biometrics Pty, Ltd.2005-01-21LNH
K111222000MRI-Q SYSTEMResonance Health Analysis Services Pty, Ltd.2011-07-28LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09355529000002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09355529000002093555290000029355529000002

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61892865300support@resonancehealth.com

Regulatory Flags#

DUNS number
740449913
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998038619FerriSmartv012024-06-07
09355529000019HepaFat-AIV1.0.02024-06-07
09355529000057FerriSmartv2.2.4-2024-06-06
09355529000095HepaFatSmartv2.0.0-2024-04-29
09355529000033T1CMR Phantom (1.5T)v1.0-2024-04-17
09355529000064T1CMR Phantom (3.0T)v1.0-2024-04-17
09355529000071T2CMR Phantomv1.0-2024-04-17
09355529000088R2*/T2* Phantomv1.0-2024-04-17
09355529000026FerriScan Phantomv1.0 (15 vials (0 to 3.2 mM))2016-11-10
09355529000040HepaFat-ScanV1.1.02023-06-16

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