T1CMR Phantom (1.5T)

Basic Information

• Brand Name: T1CMR Phantom (1.5T)
• Primary DI: 09355529000033
• Version / Model: v1.0
• Catalog Number: -
• Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Labeler DUNS: 740449913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-17
• Public Version: 1
• Public Version Date: 2024-04-25
• Public Version Status: New
• Public Device Record Key: 66c1379c-ce88-49ec-85c3-6adcc8fe4555

Device Description

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”.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXG	Phantom, Anthropomorphic, Radiographic	Radiology	892.1950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40636	MRI phantom, test object	A device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09355529000033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 13 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 13 – 40 Degrees Celsius