Drgem
2 catalogue numbers from DXC-RMH, listed by Drgem Corporation, South Korea, under Collimator, Manual, Radiographic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue 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 | Drgem Corporation, South Korea |
|---|---|
| FDA product code | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DXC-RMH | In distribution | |
| DXC-RML | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 80 |
| Claymount | Varex Imaging Nederland B.V. | 36 |
| 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 |
| 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.