Varex Imaging
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 out of the Optica 40 series
5manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | 2019-07-19 |
| 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 |
|---|---|---|
| 50149-21-OEM | Withdrawn | |
| 50149-27-OEM | Withdrawn | |
| 50129-30-OEM | Withdrawn | |
| 50129-23-SAMPLE | Withdrawn | |
| 50146-27-OEM | Withdrawn | |
| 50129-23-OEM | Withdrawn | |
| 50149-24-OEM | Withdrawn | |
| 50149-29-OEM | Withdrawn | |
| 50129-20-OEM | Withdrawn | |
| 50126-23-OEM | Withdrawn | |
| 50126-23-SAMPLE | Withdrawn | |
| 50146-21-OEM | Withdrawn | |
| 50146-30-OEM | Withdrawn | |
| 50126-24-OEM | Withdrawn | |
| 50129-24-OEM | Withdrawn | |
| 50146-24-OEM | Withdrawn | |
| 50126-29-OEM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Claymount | Varex Imaging Nederland B.V. | 30 |
| Ralco srl | Ralco SRL | 9 |
| Linear IV | Carestream Health, Inc. | 2 |
| R-300 | Shimadzu Corp. | 2 |
| iRay | iRay Imaging Technology (Haining) Limited | 1 |
| 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.