FDA Radiology AI Devices

MAIA is a medical imaging device used to take detailed digital images of the human retina without the need for pharmacological dilation. It uses confocal imaging and white light illumination to capture sharp, naturally colored retinal images, aiding clinicians in retina examination. The device also features pupil tracking and automatic perimetry for measuring retinal sensitivity and fixation analysis, improving accuracy in eye diagnostics.

The LVivo Software Application is an AI-based software platform that automates the analysis of ultrasound images, primarily to evaluate heart-left ventricle function and bladder volume. It helps clinicians by automatically detecting and calculating important medical parameters, improving diagnostic accuracy and efficiency in cardiology and related fields.

The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.

Viewer+ is an internet browser-based software intended to help pathologists view and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It aids in primary diagnosis by allowing image navigation, annotation, and measurement, ultimately supporting pathology evaluations digitally.

PLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.

DeepRESP is a cloud-based AI software tool that analyzes sleep study recordings, with or without EEG signals, to assist clinicians in diagnosing sleep disorders. It automatically marks events, calculates parameters like the Apnea-Hypopnea Index, and infers sleep stages. This helps medical professionals to efficiently assess sleep health and tailor treatments.

The Bronchoscope System by Shenzhen Sanping Image Technology Co. is a single-use flexible bronchoscope designed for use in hospital environments for adult patients. It works with an electronic endoscope imaging processor that captures images inside the airways and tracheobronchial tree using a CMOS image sensor and LED light source, then processes and displays these images on a monitor. This system helps clinicians perform endoscopic diagnosis and treatments safely and effectively with single-use, sterile instruments to reduce infection risks.

The xvision Spine system by Augmedics Ltd. is an advanced surgical navigation system that helps surgeons precisely locate anatomical structures in the spine during open or percutaneous procedures. By integrating near-eye augmented reality displays with fluoroscopic and CT images, it enables real-time visualization of tracked surgical instruments overlaid on patient anatomy, improving accuracy for procedures such as pedicle screw and iliosacral screw placement. This technology enhances surgical precision and safety, aiding clinicians in complex spine surgeries.

The FlowTriever2 Catheter is a medical device designed for the non-surgical removal of blood clots (emboli and thrombi) from peripheral blood vessels, particularly for the treatment of pulmonary embolism. It uses fluoroscopic visualization aided by radiopaque markers to guide the device through blood vessels, capturing and extracting clots to restore normal blood flow. This device helps clinicians perform thrombectomy procedures with precision, facilitating minimally invasive treatment of embolic conditions in peripheral and pulmonary vasculature.

Ziehm Vision FD is a mobile fluoroscopic X-ray system designed to provide continuous and pulsed fluoroscopic imaging during diagnostic, interventional, and surgical procedures. It helps clinicians visualize complex anatomical structures such as vascular, cardiac, and neurologic areas in real-time to better localize and treat pathological regions, improving accuracy in surgical and critical care settings. The system offers high-resolution flat panel displays, motorized and manual movement axes for precise positioning, and supports multiple peripheral interfaces, enhancing surgical workflow and patient care.