FDA Radiology AI Devices

EzSensor HD and EzSensor UHD are digital extraoral x-ray systems used for capturing high-resolution images outside the mouth, typically used in dental and radiological evaluations to assist clinicians in diagnosis and treatment planning.

SugarBug (1.x) by Bench7, Inc. is a medical image analyzer designed to assist radiology professionals by analyzing medical images. This helps clinicians in interpreting imaging studies more efficiently and accurately.

The Consona series comprises advanced diagnostic ultrasound systems used in medical imaging to help clinicians visualize internal body structures. These systems support various ultrasound applications, aiding in real-time imaging for diagnosis, treatment planning, and patient monitoring.

Fibresolve (with PCCP) is a radiology software that helps clinicians identify and refer findings related to fibrotic lung disease from medical images. It assists in detecting lung fibrosis patterns to support diagnosis and patient management.

The Adaptix Ortho350 is an X-ray tomographic system designed for radiology applications. It captures detailed layered images of anatomical structures, helping clinicians to better diagnose and treat conditions in orthopedics and other fields by providing high-resolution imaging.

BriefCase-Triage is a software tool designed to assist radiologists by automatically triaging medical images and sending notifications. It helps prioritize cases that may need urgent attention, thereby improving workflow and potentially enhancing patient care by expediting diagnosis.

The Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is a mobile X-ray imaging device that uses fluoroscopy to provide real-time moving images. It helps clinicians visualize internal structures during medical procedures, improving accuracy and patient care.

VXvue is an image processing system designed for use in radiology. It assists clinicians by enhancing the visualization of medical images, aiding in image analysis and diagnosis processes.

Cios Select is an interventional fluoroscopic X-ray system designed to assist clinicians during medical procedures by providing real-time imaging. This system helps improve procedure accuracy and patient outcomes by visualizing anatomy and instruments during interventions.

3mensio Workstation is an automated radiological image processing software designed to assist clinicians by processing medical images automatically, enhancing diagnostic efficiency and accuracy in radiology.