FDA Radiology AI Devices

The REMEX Xcam6 is a portable, handheld mobile X-ray system designed for hospital or clinic use to capture diagnostic X-ray images of patient extremities. It can be used with a flat panel detector to acquire, display, and manipulate images. It enables clinicians to obtain high-quality radiographic images conveniently and safely, aiding the diagnosis of various conditions affecting extremities.

The PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS are portable digital X-ray systems designed to provide high-quality diagnostic images of body extremities. These battery-operated portable X-ray devices use flat-panel detectors and advanced image acquisition software to produce clear, digital radiographs, aiding fast and accurate clinical diagnosis. They are intended for use in varied healthcare settings including field locations and tele-radiology setups, operated by trained medical professionals.

The !M1 mobile X-ray system by Solutions for tomorrow AB is a diagnostic mobile X-ray system designed to perform general radiography exams on pediatric and adult patients in healthcare facilities. It utilizes digital radiography technology with flat-panel detectors, offering configurations with detectors from manufacturers like Canon, Konica Minolta, and Vieworks, improving image quality and system performance. This helps clinicians obtain diagnostic images efficiently both inside and outside standard X-ray rooms, improving patient care.

The ULTRA 1040 is a portable X-ray device designed for use by trained physicians or technicians to capture X-ray images of patients' extremities. It allows for flexible diagnostic imaging outside traditional settings, helping clinicians assess bone and joint conditions conveniently. It supports use with an X-ray detector and image processing software for image acquisition and processing.

The TOPAZ Mobile X-ray System by DRGEM Corporation is a portable X-ray machine designed to obtain high-quality digital radiographic images for patients who cannot be moved to the radiology department. It features a motorized drive mechanism for easy mobility, a flat panel digital detector for rapid image acquisition, and enhanced software for image processing. The system supports various flat panel detectors and includes a touchscreen interface to facilitate workflow, helping clinicians quickly and accurately examine patients in bed or other immobile settings.

The DRX-Revolution Mobile X-ray System by Carestream Health is a portable digital X-ray system designed for bedside or mobile use, enabling radiographic examinations of various anatomical regions on pediatric and adult patients. It facilitates image acquisition and processing outside standard stationary X-ray rooms, helping clinicians to obtain high-quality diagnostic images conveniently and efficiently in different clinical settings.

The uDR 380i Pro from Shanghai United Imaging Healthcare Co.,Ltd. is a mobile digital radiography system that captures X-ray images of human anatomy for medical diagnosis. Designed for use on both adult and pediatric patients, it is especially useful for patients who cannot be moved to a traditional radiology room. The system includes flat panel detectors, a high-power generator, and a maneuverable design, enabling clinicians to obtain high-quality diagnostic images at the point of care.

The GM85 Digital Mobile X-ray Imaging System by Samsung Electronics is a mobile X-ray device designed to generate digital radiographic images of human anatomy. It uses advanced digital detectors and software for image processing and communication with hospital information systems, aiding clinicians in efficient and accurate imaging workflows.