MULTIX Impact; MULTIX Impact C
Siemens Medical Solutions USA, Inc.The MULTIX Impact and MULTIX Impact C are hospital and clinic X-ray systems designed for taking radiographic images of the whole body, including skull, chest, abdomen, and extremities, for patients of all ages and sizes. These systems use digital detectors to create diagnostic images and offer AI-based features to assist with image acquisition, such as automatic planning of exam ranges and measurements, improving efficiency and consistency for radiologic technologists.
Intended Use
The MULTIX Impact and MULTIX Impact C are radiographic systems for use in hospitals, clinics, and medical practices, enabling radiographic exposures of the whole body (skull, chest, abdomen, extremities) in pediatric, adult, and bariatric patients, in sitting, standing, or prone positions, and not intended for mammography.
Technology
The system consists of modular X-ray components (X-ray tube, wall stand, patient table, generator, portable wireless/fixed detectors) with optional floor or ceiling mounting. Digital detectors convert X-rays into images, and software includes AI-based features such as auto thorax collimation, auto table-to-object distance measurement, and auto full-spine/long-leg collimation. Recent updates include new hardware interfaces, Windows 10 OS, workflow improvements, and an upgraded in-house ortho (stitching) algorithm.
Performance
Performance and functionality testing (verification and validation) was performed on new and updated hardware and software. Key areas tested included the updated ortho stitching algorithm (accuracy and uniformity of stitched images for long-leg and full-spine exams), integration into workflow, and overall system safety and effectiveness. The device was tested against standards for electrical, mechanical, software safety, EMC, and cybersecurity, with no impact to safety or effectiveness from updates.
Predicate Devices
No predicate devices specified
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