T1CMR Phantom (3.0t)
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)…
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 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
Record
| 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
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 13 to 40 °C; Storage environment temperature 13 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| v1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bolus | Medtec LLC | 14 |
| LiquiPhil™ | Providus Holdings, Inc. | 14 |
| Rando® | Providus Holdings, Inc. | 8 |
| Clearsight Bolus | Clearsight RT LLC | 2 |
| miniPhantom R | IBA Dosimetry GmbH | 2 |
| Gafchromic™ | Ashland Specialty Ingredients, G.P. | 2 |
| StereoPHAN | Sun Nuclear Corporation | 1 |
| myQA® SRS Phantom | IBA Dosimetry GmbH | 1 |
| SNC Phantom (MV-QA) | Sun Nuclear Corporation | 1 |
| R2*/T2* Phantom | Resonance Health Analysis Services PTY Ltd | 1 |
| myQA® SRS Phantom Cyberknife | IBA Dosimetry GmbH | 1 |
| Alignment Block | Medtec LLC | 1 |
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.