FDA Radiology AI Devices

The InkSpace Imaging Small Body Array is a flexible, receive-only MRI coil designed for use with Siemens 1.5T MRI systems. It helps capture high-quality diagnostic images of various body parts such as the heart, spine, joints, and prostate, assisting physicians and radiologists in making accurate diagnoses. The coil's flexible design improves patient comfort and scanning convenience.

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 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 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.

Roche Digital Pathology Dx is a digital slide scanning and management system designed to assist pathologists by creating, viewing, and managing high-resolution digital images of pathology slides prepared from formalin-fixed paraffin-embedded tissue. It includes slide scanners and software for image acquisition and management, enabling pathologists to review digital slides instead of traditional light microscopy.

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.