FDA Radiology AI Devices

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.

a2z-Unified-Triage is an AI-powered software designed to assist medical specialists by analyzing abdominal and pelvic CT scans in adults to identify and prioritize cases suspected of seven specific conditions. It flags these findings for faster clinical review, improving workflow efficiency without altering original images or making definitive diagnoses.

The Voluson Expert Series (models 18, 20, and 22) are advanced ultrasound systems designed for use by trained healthcare professionals in hospitals or medical clinics. They offer comprehensive imaging capabilities including 2D, Doppler, 3D/4D, elastography, and shear wave imaging modes. The devices support various clinical applications such as fetal and obstetric imaging, abdominal, cardiac, small organ, pediatric, musculoskeletal, vascular, and gynecology imaging. They incorporate AI features like SonoLyst for assisting in first trimester pregnancy assessments. The systems provide high-quality real-time imaging and analysis, helping clinicians perform accurate diagnoses and patient monitoring.