VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in…
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), Guangdong (1).
Record
Regulatory record for Clarox plus | Listed by | VSI Co., Ltd., South Korea |
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Manufacturer |
| 510(k) | K221417 |
| Record published | 2022-10-03 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment humidity 30 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 76 to 106 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -40 to 70 °C |
| Packaging | Cardboard box of 5 |
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.