FDA Radiology AI Devices

The Yushan X-Ray Flat Panel Detector is a digital imaging device designed to capture high-quality X-ray images for radiology. It helps clinicians obtain clear diagnostic images efficiently, supporting better patient diagnosis and care.

The SKR 3000 is a digital radiography device by Konica Minolta designed to produce high-quality X-ray images of the human body for general-purpose diagnostic procedures. It replaces traditional film-based systems and includes features like advanced image processing and wireless connectivity. Its added indication includes pediatric imaging, helping clinicians accurately diagnose patients of all ages.

The Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited are digital imaging devices used with specialized software to capture and process X-ray images of all body parts for general radiographic applications. They convert X-rays into high-quality digital images, aiding radiologists in diagnosis by replacing traditional film-based systems.

The EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.

The EXPD-N series by DRTECH Corporation is a digital flat panel X-ray detector designed for use in digital radiography. It replaces traditional film or screen-based X-ray systems and aids clinicians by providing high-quality digital images for general diagnostic imaging of human anatomy in both adults and children. It supports improved imaging performance and faster image acquisition for better diagnosis.

The Lux HD 35 Detector and Lux HD 43 Detector by iRay Imaging Technology are digital flat panel X-ray detectors designed to provide high-resolution digital radiographic imaging for adult and pediatric patients. These detectors replace traditional film/screen systems in general radiography and connect wirelessly or via wired interfaces to DR systems, aiding clinicians in capturing and processing X-ray images for diagnosis efficiently.

ExamVue Apex is a flat panel digital X-ray detector system designed for use in general and specialist radiology, including mobile x-ray systems. It captures digital images by converting x-rays to electronic signals, facilitating efficient image acquisition and management without film. The system includes advanced software for image processing, presentation, and storage, helping clinicians to acquire high-quality diagnostic images effectively.

The Yushan X-Ray Flat Panel Detector is a digital radiography detector that captures high-quality X-ray images of the human anatomy for general projection radiographic use. It helps healthcare professionals obtain clear images quickly and efficiently, suitable for many standard imaging applications except mammography, fluoroscopy, tomography, and angiography. The device supports wired and wireless operation and includes software for image processing and workflow management, facilitating smoother clinical integration and better patient care.

The SKR 3000 is a digital X-ray imaging system designed to replace traditional film/screen radiography in general diagnostic radiographic procedures. It uses an advanced flat-panel detector with antibacterial properties and wireless communication capabilities to capture detailed digital images of the human body, helping clinicians efficiently obtain and manage diagnostic images. This system is intended for adult use and excludes applications like mammography, fluoroscopy, and angiography.

The VIVIX-S 1751S is a digital flat panel X-ray detector designed for general-purpose diagnostic radiographic procedures. It replaces traditional film/screen X-ray systems by capturing and converting X-ray photons into digital images. This helps clinicians obtain high-quality digital X-ray images quickly and efficiently for better diagnosis.