Vareximaging
x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device of the Optica 40 series.
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 | Varex Imaging Nederland B.V., Netherlands |
|---|---|
| FDA product code | IZW |
| Device type | Collimator, Automatic, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-12 |
| Record revised | 2025-05-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50126-20-OEM | Withdrawn |
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 |
| iRay | iRay Imaging Technology (Haining) Limited | 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.