FDA Radiology AI Devices

Bunkerhill Abdominal Aortic Quantification (AAQ) is AI software designed to analyze radiological images to quantify the abdominal aorta. This helps clinicians assess and monitor conditions related to the abdominal aorta more efficiently and accurately.

Velacur One (LI-1100) is a portable ultrasound elastography device designed to non-invasively assess liver tissue stiffness, ultrasound attenuation, and fat content by measuring shear wave speed and ultrasound properties. It assists trained clinicians in managing liver diseases including hepatic steatosis by providing quantitative imaging data at the point of care in clinics and hospitals.

The Shear Wave Quantificational Ultrasound Diagnostic System is a portable ultrasound device designed to measure liver tissue stiffness using shear wave elastography and estimate tissue characteristics such as Ultrasound Attenuation Parameter (UAP). It provides non-invasive aid in diagnosing, managing, and monitoring adult and pediatric patients with liver diseases by delivering both ultrasound images and quantitative data on liver health. The system helps clinicians assess liver conditions efficiently and accurately in a clinical setting.

The Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.

BunkerHill BMD is an AI-based software tool designed to estimate bone mineral density from existing CT scans of the spine in adults aged 30 and over. It helps clinicians identify low bone density without requiring dedicated bone densitometry scans, supporting retrospective assessment and aiding clinical decision-making.

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.

BioTraceIO Precision (2.0) is a medical software that assists physicians by analyzing ultrasound images captured during liver ablation procedures to visualize and predict the ablation zone. It helps clinicians assess the effectiveness of radiofrequency or microwave ablation treatments by correlating ultrasound data with contrast-enhanced CT scans obtained post-procedure, improving decision-making while providing adjunctive visual information during and after treatment.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips are advanced ultrasound imaging systems used for a wide range of diagnostic applications across many body regions. The newly introduced Auto ElastQ software feature assists clinicians by automatically selecting the most stable frames and regions of interest for liver stiffness measurements with 2D shear wave elastography, making the diagnostic workflow easier and potentially more reliable. This helps healthcare professionals to assess liver tissue characteristics more efficiently during ultrasound exams.

IRISeg is a software application developed by Intuitive Surgical that utilizes machine learning to assist with the segmentation of contrast-enhanced kidney CT scans and generates 3D models for preoperative surgical planning and intraoperative display. It provides both automatic and manual tools to segment kidney structures, helping clinicians visualize anatomy more efficiently and accurately for better patient management.

DrAid™ for Liver Segmentation is a web-based AI software that assists healthcare professionals in analyzing liver images from CT scans. It generates semi-automated liver segmentation and allows physicians to manually refine these segmentations and identify lesions, aiding in evaluation and treatment planning without providing direct diagnosis.