FDA Radiology AI Devices

The Diagnostic X-ray System is a mobile fluoroscopic X-ray system with a C-arm and digital imaging capabilities. It is used by trained medical professionals for real-time imaging guidance during diagnostic, interventional, and surgical procedures, helping clinicians visualize inside the body with X-rays from various angles.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.

The 6450 Ultrasound System (MyLabE80 and MyLabE85) is a versatile diagnostic ultrasound machine designed for various clinical applications including cardiac, vascular, general imaging, and women's health. It supports multiple ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians visualize and assess internal body structures in real-time, aiding in diagnosis and treatment planning.

The Diagnostic Ultrasound System MX6 series by Shenzhen Mindray Bio-medical Electronics Co., LTD is a general-purpose, software-controlled ultrasound imaging device for a wide range of clinical applications including adult, pediatric, and neonatal exams. It supports various ultrasound modes such as B-mode, Doppler, Color Doppler, 3D/4D imaging, elastography, and contrast imaging. This device aids healthcare professionals in capturing, measuring, and analyzing ultrasound images to support medical diagnosis across multiple body regions such as abdomen, obstetrics, gynecology, cardiac, and musculoskeletal systems.

The iBSM is a wireless patient monitoring system designed for hospital use on non-critical patients aged 18 and older. It continuously displays vital signs such as ECG waveforms, heart rate, respiratory rate, oxygen saturation, and blood pressure using biocompatible sensors. It aids clinicians by providing real-time physiological data, visual and audio alarms, and patient orientation notifications to help prevent complications like pressure ulcers.

Mixed Reality Spine Navigation is an accessory software used with Brainlab's Spine & Trauma Navigation platform. It employs a mixed reality headset (Magic Leap 2 Medtech) to provide surgeons with 2D and 3D floating visualizations of the patient's spine anatomy and tracked surgical instruments during pedicle screw placement surgery, enhancing intraoperative navigation and precision.

The MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a portable fluoroscopic X-ray system designed for real-time imaging and guidance during diagnostic radiography and surgical procedures of the extremities. Its mobility and advanced imaging technology facilitate easy positioning and high-quality visualization to assist medical professionals in various clinical settings, except neonates and mammography.

InferRead Lung CT.AI is an AI-powered software tool designed to assist radiologists in detecting and analyzing pulmonary nodules 4mm or larger on chest CT scans of asymptomatic patients aged 55 and older. It provides automatic detection, segmentation, and tracking of nodules over time, helping clinicians identify, measure, and localize lung nodules efficiently. This tool supports early lung nodule detection and monitoring, aiding in lung cancer screening and diagnosis.

OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.