T2CMR Phantom

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…

Registry build 21.09.26

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”.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code IXG
Manufacturer City Province Registered as Device types
Guangdong Meicen Medical Equipment Co., Ltd. Foshan Guangdong Manufacturer 7

Record

Regulatory record for T2CMR Phantom
Listed by Resonance Health Analysis Services PTY Ltd, Australia
FDA product code IXG
Device type Phantom, Anthropomorphic, Radiographic
Device class Class 1
Regulation 21 CFR 892.1950
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-04-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for T2CMR Phantom
Catalogue number Size Status
v1.0 In distribution

Same Product Code

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Showing 12 of 33. All products under Phantom, Anthropomorphic, Radiographic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer