FDA Radiology AI Devices

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a mobile, software-controlled ultrasound imaging device that supports various imaging modes including B-mode, Color Doppler, Pulsed Wave Doppler, and M-mode. It is designed for diagnostic ultrasound imaging and fluid flow analysis across many anatomical areas such as fetal, abdominal, musculoskeletal, cardiac, ophthalmic, and more. The device is compatible with iOS and Android systems and includes different USB transducers. The recent update adds an ocular preset to enable ophthalmic imaging, expanding its clinical utility. This portable ultrasound system helps clinicians obtain high-resolution images and flow data to support diagnosis and procedural decisions.

The !M1 mobile X-ray system by Solutions for tomorrow AB is a diagnostic mobile X-ray system designed to perform general radiography exams on pediatric and adult patients in healthcare facilities. It utilizes digital radiography technology with flat-panel detectors, offering configurations with detectors from manufacturers like Canon, Konica Minolta, and Vieworks, improving image quality and system performance. This helps clinicians obtain diagnostic images efficiently both inside and outside standard X-ray rooms, improving patient care.

The Arthrex Synergy Vision Endoscopic Imaging System is an advanced camera system used in endoscopic surgery to provide live imaging in visible and near-infrared light. It helps surgeons visualize vessels, blood flow, lymphatic system, and tissues during minimally invasive surgeries, improving surgical precision and patient outcomes.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.

The Resolve Fundus Camera by Optain Health, Inc. is an automatic eye-fundus camera designed to take high-quality digital images of the retina with or without pupil dilation. It uses infrared tracking and autofocus to capture clear images that aid clinicians in evaluating ocular health. The device enhances diagnosis and monitoring of eye conditions by providing precise, easily accessible retinal images.

The LumiRex Bronchoscope is a single-use flexible endoscope designed to provide real-time video imaging of the airways and tracheobronchial tree. It aids clinicians during endoscopic procedures by allowing visualization through a thin tube equipped with a camera and light source. The device can operate in wired or wireless modes, enabling easier maneuverability, and is designed for use in hospitals.

Persona C HR is a mobile C-arm X-ray device used to provide real-time fluoroscopic imaging guidance during various diagnostic, interventional, and surgical procedures. It helps clinicians visualize patient anatomy with high-quality images to assist in precise and effective treatment, excluding pediatric patients.

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

The eHertz Functional Series Diagnostic Ultrasound System by eSonic Technology is a portable ultrasound imaging device designed for general diagnostic use across adults, pregnant women, and pediatric patients. It supports multiple imaging modes including B-mode, Doppler, and elastography among others, enabling healthcare professionals to visualize and analyze the human body and fluid for various exams such as fetal, abdominal, cardiac, and musculoskeletal. This system enhances image quality through features like micro blood flow imaging and image optimization, aiding clinicians in making more accurate assessments.

EchoGuide is a portable 3D ultrasound imaging device designed to assist healthcare providers in identifying the proper vascular access points on the skin for patients with arteriovenous fistulas or grafts. It automates ultrasound imaging acquisition and displays live coronal plane images to guide clinicians during cannulation, improving accuracy and ease of use during the procedure.