FDA Radiology AI Devices

The OptiMap™ System is a medical device used during electrophysiology procedures to help physicians analyze and visualize complex cardiac arrhythmias. It uses a 64-electrode basket catheter to capture electrogram signals within the heart, which are processed with proprietary algorithms to create detailed maps of electrical flow and activation pathways. This assists clinicians in diagnosing and understanding heart rhythm disorders more effectively.

DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.

NeuroMatch is a cloud-based software that assists neurologists by reviewing and analyzing EEG recordings to detect seizures and spikes, reduce artifacts, and visualize brain electrical activity through 3D source localization on an idealized head model. It helps clinicians understand brain activity over time by displaying quantitative trends, improving EEG assessment without providing diagnostic conclusions.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

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.

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.

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 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.

The Philips Lumify Diagnostic Ultrasound System is a portable medical ultrasound device that allows clinicians to capture high-resolution ultrasound images and analyze blood flow in various body regions. It supports multiple imaging modes and is compatible with mobile devices, helping healthcare professionals perform diagnostic ultrasound in many clinical applications, including obstetrics, gynecology, musculoskeletal, cardiac, and vascular imaging. The addition of the C9-4ec transducer expands its use to trans-vaginal imaging and fertility assessments, improving diagnostic capabilities in reproductive health.

Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.