Phantom, Anthropomorphic, Radiographic
MRI Phantom
1manufacturer
1catalogue number
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | IXG |
| Device type | Phantom, Anthropomorphic, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1950 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-08-29 |
| Record revised | 2023-09-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71934573 | 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.