FDA Radiology AI Devices

The Dendrite Imaging System is a handheld device used during surgery to capture and display autofluorescent images of nerves in real time. It helps surgeons locate nerve tissue by illuminating tissue with near ultraviolet light, which causes nerves to fluoresce naturally. The images are captured by a camera and displayed on a touchscreen, assisting surgeons to better identify and preserve nerves during procedures without replacing visual assessment.

The uDR Arria & uDR Aris are stationary digital X-ray imaging systems designed to acquire high-quality 2D X-ray images of various body parts to support radiologists and clinicians in diagnosing medical conditions. They include AI-assisted features like uVision for patient positioning and uAid for image quality assessment, helping improve clinical workflow and image quality control.

The OEC One CFD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during various diagnostic, interventional, and surgical procedures in adults and pediatric patients. It includes advanced features like deep learning-based Trajectory Pointer to aid in positioning Kirschner-wires, and Image Stitching to create composite images for improved visualization. These tools help clinicians better visualize anatomy and aid precise interventions, improving clinical workflow and patient care.

Scaida BrainCT-ICH is an AI-powered software that analyzes non-contrast head CT scans of adult patients to detect suspected intracranial hemorrhages. It helps radiologists by notifying them of potential positive cases to prioritize and triage workflow efficiently, improving timely diagnosis and care without altering original images.

The NX01 is a wearable EEG device designed as earbuds that continuously record one channel of brain electrical activity. Intended for use in healthcare and home settings, it allows licensed medical professionals to access EEG data for patient monitoring. By integrating dry electrodes into earbuds, the device provides a compact and comfortable solution for long-term brain activity recording in adults and pediatric patients 6 years and older.

The PennPET Explorer Positron Emission Tomograph is a diagnostic imaging system that combines PET and CT imaging to detect and monitor various diseases such as cancer, heart, and brain conditions. It features a long axial field-of-view PET scanner that images large body regions in a single scan without moving the patient, providing improved sensitivity and time-of-flight resolution to help clinicians in diagnosis and treatment planning.

The FEops HEARTguide Simulation Application is a specialized software tool that assists clinicians in planning heart implant procedures by simulating the deformation of cardiac device implants. It uses patient-specific 3D anatomical models derived from medical imaging to predict how a left atrial appendage occlusion device will fit, helping clinicians choose the right device size and placement before surgery.

The 7600 Ultrasound System by Esaote is a portable ultrasound imaging device designed for diagnostic ultrasound across multiple clinical domains, including cardiac, vascular, general imaging, and women's health. It supports various ultrasound modes like B-Mode, Doppler, 3D/4D imaging, and elastosonography, enabling detailed visualization and analysis of body structures to aid clinicians in diagnosis and patient care.

The RCT700 is a dental CBCT (cone beam computed tomography) and panoramic X-ray imaging system with an optional cephalometric feature. It is intended for radiographic examination of the dento-maxillofacial area, sinuses, TMJ, airway, and ENT structures for both adult and pediatric patients. The device helps dentists and other qualified health professionals obtain high-quality 3D and 2D images to assist in diagnosis and orthodontic treatment assessment.

HALO AP Dx is a software-only device that helps pathologists review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It supports quality control and improves workflow by providing image manipulation tools such as zoom, pan, measurement, and annotation within browser-based interfaces, facilitating primary diagnosis.