DEVICE: FerriScan, Cardiac T2* (09355529000002)
Device Identifier (DI) Information
FerriScan, Cardiac T2*
4.0.0
In Commercial Distribution
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
4.0.0
In Commercial Distribution
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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40872 | MRI system application software |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
LNH | System, Nuclear Magnetic Resonance Imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K043271 | 000 |
K111222 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c0a7b8f1-a95b-479e-84f6-ddc7a71a4758
June 27, 2023
1
June 19, 2023
June 27, 2023
1
June 19, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61892865300
support@resonancehealth.com
support@resonancehealth.com