R2*/T2* Phantom
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that…
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
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 |
| myQA® SRS Phantom Cyberknife | IBA Dosimetry GmbH | 1 |
| Alignment Block | Medtec LLC | 1 |
| MapPHAN (10cm) | Sun Nuclear Corporation | 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.