T2CMR Phantom -

GUDID 09355529000071

Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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Primary Device ID09355529000071
NIH Device Record Key4b20d26f-43c9-40ef-b661-f340cd570f13
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2CMR Phantom
Version Model Numberv1.0
Catalog Number-
Company DUNS740449913
Company NameRESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com
Phone+61892865300
Emailquality@resonancehealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109355529000071 [Primary]

FDA Product Code

IXGPhantom, Anthropomorphic, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-25
Device Publish Date2024-04-17

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 Phantom2024-04-25Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.
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*2023-06-27 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

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