Collimare
Collimator, Portable Certified, 125kVp, LED 25W, MX
2manufacturers in China registered for this device type
7catalogue 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 | Collimare, LLC, United States |
|---|---|
| FDA product code | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Manufacturer |
| 510(k) | K073124 |
| Record published | 2016-09-28 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 55 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature -25 to 55 °C; Handling environment humidity 5 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTL-150-0001-C | In distribution | |
| CPL-125-MX01-C | In distribution | |
| CML-150-0001-C | In distribution | |
| CML-150-CMR1-C | In distribution | |
| CML-125-0001-C | In distribution | |
| CPL-125-SR01-C | In distribution | |
| CPL-125-0001-C | 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 |
| 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.