Identity
- Trade Name
- T2CMR Phantom FDA UDI
- Generic Name
- MRI phantom, test object FDA UDI
- Device Name
- 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”. FDA UDI
- Model / Reference
- v1.0 FDA UDI
- Description
- 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”. FDA UDI
Identifiers
- Catalog Number
- - FDA UDI
- Primary DI / UDI-DI
- 09355529000071 FDA UDI
- FDA Product Code
- IXG FDA UDI
- GMDN Term
- MRI phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI phantom, test object
T2CMR Phantom by Resonance Health Analysis Services Pty, Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Resonance Health Analysis Services Pty, Ltd.
Sources (2)
- FDA UDI 4b20d26f-43c9-40ef-b661-f340cd570f13 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026