Claymount
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 20 series
2manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-11-07 |
| Record revised | 2025-05-20 (version 7) |
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 |
|---|---|---|
| 50251-10-USA | Withdrawn | |
| 50601-11-OEM | Withdrawn | |
| 50600-11-OEM | Withdrawn | |
| 50600-10-DEU | Withdrawn | |
| 50601-10-USA | Withdrawn | |
| 50251-10-DEU | Withdrawn | |
| 50600-14-OEM | Withdrawn | |
| 50600-13-OEM | Withdrawn | |
| 50250-11-USA | Withdrawn | |
| 50600-11-USA | Withdrawn | |
| 50251-11-OEM | Withdrawn | |
| 50250-13-OEM | Withdrawn | |
| 50601-12-OEM | Withdrawn | |
| 50251-10-OEM | Withdrawn | |
| 50251-10-GBR | Withdrawn | |
| 50251-11-GBR | Withdrawn | |
| 50250-11-OEM | Withdrawn | |
| 50601-13-OEM | Withdrawn | |
| 50250-14-OEM | Withdrawn | |
| 50250-11-GBR | Withdrawn | |
| 50250-10-OEM | Withdrawn | |
| 50250-10-USA | Withdrawn | |
| 50250-10-GBR | Withdrawn | |
| 50601-11-USA | Withdrawn | |
| 50251-14-OEM | Withdrawn | |
| 50251-12-OEM | Withdrawn | |
| 50601-14-OEM | Withdrawn | |
| 50600-10-USA | Withdrawn | |
| 50601-10-OEM | Withdrawn | |
| 50600-12-OEM | Withdrawn | |
| 50601-10-DEU | Withdrawn | |
| 50250-10-DEU | Withdrawn | |
| 50251-11-USA | Withdrawn | |
| 50600-10-OEM | Withdrawn | |
| 50251-13-OEM | Withdrawn | |
| 50250-12-OEM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 80 |
| Huestis Medical Collimator | Huestis Machine Corp. | 12 |
| Collimare | Collimare, LLC | 7 |
| R-20J | Shimadzu Corp. | 6 |
| Linear MC 150 | Carestream Health, Inc. | 4 |
| Ralco srl | Ralco SRL | 3 |
| iRay | iRay Imaging Technology (Haining) Limited | 3 |
| R-300 | Shimadzu Corp. | 3 |
| Drgem | Drgem Corporation | 2 |
| Rinn® | Dentsply LLC | 2 |
| Huestis Medical Collilmator | Huestis Machine Corp. | 1 |
| Summit X-ray Collimator | Summit Industries, LLC | 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.