T1CMR Phantom (1.5T) -

GUDID 09355529000033

The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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• Primary Device ID: 09355529000033
• NIH Device Record Key: 66c1379c-ce88-49ec-85c3-6adcc8fe4555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T1CMR Phantom (1.5T)
• Version Model Number: v1.0
• Catalog Number: -
• Company DUNS: 740449913
• Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09355529000033 [Primary]

FDA Product Code

• IXG: Phantom, Anthropomorphic, Radiographic

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: 2024-04-25
• Device Publish Date: 2024-04-17

Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

• 09355529000033 - T1CMR Phantom (1.5T): 2024-04-25The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
• 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
• 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-AI: 2023-06-26 Standalone software platform designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to gener
• 09355529000040 - HepaFat-Scan: 2023-06-26 Standalone software application to facilitate the import and visualization of multi slice, gradient echo MRI data sets encompass