FDA Radiology AI Devices

The aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.

Lightning Viewer is a web-based medical image viewing software that allows healthcare professionals to review, manipulate, and annotate diagnostic images from various modalities. It supports major desktop browsers, offers advanced visualization tools like 3D MPR and MIP, and integrates with PACS systems to facilitate efficient radiology workflows and aid clinicians in making diagnostic decisions.

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 OrthoNext Platform System is a web-based software that helps healthcare professionals plan orthopedic surgeries and treatments by overlaying product templates on X-ray images and providing measurement and simulation tools. It assists in both preoperative and postoperative planning, enabling clinicians to make informed decisions by digitally visualizing and measuring treatment options.

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 uMI Panvivo is a PET/CT medical imaging system designed to provide combined anatomical and functional images for clinicians. It uses PET to show distribution of radiopharmaceuticals and CT to provide detailed anatomical information. The system supports assessment of metabolic and physiologic functions across various parts of the body including oncology, neurology, and infection imaging. It can also assist in treatment planning for radiotherapy and interventional radiology, improving diagnostic accuracy and patient care.

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 Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.