Iray
Catalogue number CRUX RF10, listed by iRay Imaging Technology (Haining) Limited, China, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Zhejiang (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | iRay Imaging Technology (Haining) Limited, China |
|---|---|
| FDA product code | IZW |
| Device type | Collimator, Automatic, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRUX RF10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Claymount | Varex Imaging Nederland B.V. | 30 |
| Varex Imaging | Varex Imaging Nederland B.V. | 17 |
| Ralco srl | Ralco SRL | 9 |
| Linear IV | Carestream Health, Inc. | 2 |
| R-300 | Shimadzu Corp. | 2 |
| Vareximaging | Varex Imaging Nederland B.V. | 1 |
| Collimator Cradle 512 asm | Philips Digital Mammography Sweden AB | 1 |
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.