Device Dossier
X-ray system, diagnostic, general-purpose, mobile, digital
Device Dossier for X-ray system, diagnostic, general-purpose, mobile, digital (X-ray system, diagnostic, general-purpose, mobile, digital, Class IIb,…
- GMDN category: X-ray system, diagnostic, general-purpose, mobile, digital
Intended purpose
The TOPAZ Mobile DR System, is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammography, bone density, fluoroscopy and angiography applications. Mobile X-Ray system is a system providing state-of-the-art image quality, user interface; making the system easy to use and reliable while providing high quality radiographic images with reduced dose. Mobile X-Ray system may be moved quietly and smoothly with motor drive mechanism The core part of x-ray source adopts high quality tube assembly, x-ray collimator, HV cable assembly and high frequency x-ray generator with excellent performance, lifetime and stability. Direct radiography via flat panel detector improves workflow, exam speed and comfort with efficiency. Digital flat panel detector with CsI screen provides excellent spatial resolution, MTF, DQE and stability based on fine pixel pitch. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator which have worldwide reputation on excellent performance, lifetime and stability. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator’s pre-programmed exposure technique.