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.

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.

RiasDR is a software product designed to acquire and process digital radiographic images, helping clinicians by efficiently managing and enhancing X-ray images for diagnosis and treatment planning.

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.

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.

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 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 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 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 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.