LUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical SolutionsLUMINOS Q.namix T and LUMINOS Q.namix R are advanced multifunctional fluoroscopic X-ray systems designed to visualize anatomical structures by converting X-ray patterns into visible images. These systems support routine and specialized imaging such as gastrointestinal, urogenital, arthrography, angiography, and pediatric imaging, aiding clinicians in diagnosis and treatment.
Intended Use
Devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image, suitable for routine radiography and fluoroscopy including gastrointestinal, urogenital, arthrography, angiography, and pediatrics; not for mammography.
Technology
The systems are multifunctional, modular fluoroscopic X-ray systems equipped with components such as a fluoroscopy table, X-ray tubes, image detectors, and monitors. They use new state-of-the-art X-ray generators and employ image processing software (myExam IQ) with AI-based auto cropping to enhance image quality. They operate via touch interfaces and support standard imaging techniques such as radiography and pulsed fluoroscopy.
Performance
The devices underwent extensive non-clinical testing including compliance with electrical safety, radiation protection, software lifecycle, and usability standards. Clinical image quality evaluations were conducted by experts and confirmed diagnostic adequacy. Risk management and integration testing ensured safety and effectiveness.
Predicate Devices
No predicate devices specified
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