FDA Radiology AI Devices

PROMO is a mobile X-ray system designed for use in radiology to capture diagnostic images. This device helps clinicians by enabling flexible and convenient imaging at the point of care, potentially integrating AI for image processing or analysis to support clinical decisions.

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 INNOVISION-P5 is a mobile X-Ray system designed to assist clinicians in acquiring X-Ray images at the point of care. This device enables flexible and mobile radiographic imaging, supporting patient diagnosis and treatment planning.

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.

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 Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.