FDA Radiology AI Devices

The INNOVISION-DXII is a stationary X-Ray system used in radiology to capture high-quality X-ray images. It helps clinicians by providing reliable imaging for diagnosing various conditions, facilitating accurate patient assessment and treatment planning.

YSIO X.pree is a modular digital X-ray system designed to visualize anatomical structures across the whole body, including the skull, chest, abdomen, and extremities. It helps clinicians by producing high-quality X-ray images that support diagnosis and therapy decisions. The system features updated hardware and software, including a new wireless detector and AI-based auto-cropping and collimation capabilities, enhancing workflow efficiency and image quality.

The GXR-Series Diagnostic X-Ray System by DRGEM Corporation is a stationary X-ray system designed for medical professionals to capture human anatomical images using X-rays. The system includes various device models with features like automatic calibration, digital flat panel detectors for direct radiography, and advanced image processing software to enhance image quality and workflow efficiency. It helps clinicians by providing high-quality radiographic images for diagnostic purposes while optimizing exposure settings and reducing downtime through remote system diagnosis.

The INNOVISION-EXII is a stationary digital radiography X-ray system designed for obtaining radiographic images of various anatomical parts of the human body in clinical environments. It supports imaging for both pediatric and adult patients, converting X-ray signals into digital DICOM images to assist clinicians in diagnostic screening. The system incorporates imaging software for processing images and is operated by trained radiologic technologists. It is suitable for imaging areas such as head, spine, chest, and abdomen and is not intended for mammography, angiography, interventional, or fluoroscopy uses.

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

The EXSYS DEXi is a stationary X-ray system designed for generating radiographic images of human anatomy for general diagnostic purposes. It functions by acquiring images through radiation exposure and processing these images at a workstation to provide anatomical information. This system supports clinicians in diagnosing a wide range of conditions by delivering high-quality digital radiographs, and it is not intended for mammography.

Definium Pace Select ET is a digital radiography system designed to produce detailed X-ray images of multiple body parts including the skull, spine, chest, abdomen, and extremities for patients of all ages. It features advanced motorized components for positioning and enhances image acquisition with options like image pasting to stitch sequential images, improving workflow and diagnostic capabilities. The system is intended for routine radiography exams and helps clinicians by providing high-quality digital X-ray images that can be easily reviewed and shared.

YSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.

YSIO MAX is a modular stationary X-ray imaging system designed for hospitals and clinics. It enables full-body radiographic and tomographic exposures and supports various patient positions. The system includes integrated and portable digital detectors that convert X-rays into diagnostic electronic images. It helps clinicians by offering efficient positioning and image processing, including optional AI-based soft tissue enhancement for chest X-rays, facilitating more accurate and timely diagnosis.