FDA Radiology AI Devices

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

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.

NeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

Strain AI is a medical software device that analyzes cardiac ultrasound images to measure global longitudinal strain (GLS), helping clinicians assess heart function in adult patients. It integrates with existing ultrasound devices to provide quantitative strain measurements, supporting diagnostic evaluation without requiring manual interpretation of images.