Identity
- Trade Name
- T1CMR Phantom (1.5T) FDA UDI
- Generic Name
- MRI phantom, test object FDA UDI
- Device Name
- 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”. FDA UDI
- Model / Reference
- v1.0 FDA UDI
- 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”. FDA UDI
Identifiers
- Catalog Number
- - FDA UDI
- Primary DI / UDI-DI
- 09355529000033 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
T1CMR Phantom (1.5T) 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 66c1379c-ce88-49ec-85c3-6adcc8fe4555 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026