FDA Radiology AI Devices

DeepRhythmAI is a cloud-based AI software that automatically analyzes ECG data from one or two leads to detect cardiac arrhythmias. It supports integration with various ECG recording devices and systems, providing clinicians with supportive analysis to aid in diagnosis, improving cardiac rhythm assessment accessibility and efficiency.

The RadiForce MX317W-PA is a color LCD monitor designed for displaying digital images of histopathology slides acquired from whole-slide imaging scanners. It aids pathologists in the review and interpretation of these slides for primary diagnosis by providing high-quality image visualization with calibrated display modes and color accuracy.

Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.

Clever One is dental imaging software designed to acquire, process, view, and analyze 2D and 3D medical images from dental CT, panoramic, cephalometric, and intraoral imaging devices. It helps clinicians by providing advanced visualization and analytic tools such as bone density analysis, implant planning, and multi-planar reconstructions, facilitating more accurate diagnostics and treatment plans.

DEEPECHO is a cloud-based AI software for fetal ultrasound image analysis. It helps trained healthcare professionals detect important fetal views in ultrasound scans and suggests caliper placement for accurate biometric measurements like head circumference and femur length. The software supports real-time image streaming and exam management to improve fetal assessment during pregnancy between 14 and 41 weeks, aiding clinicians to make informed decisions efficiently.

NeuroMatch is a cloud-based software that assists neurologists by reviewing and analyzing EEG recordings to detect seizures and spikes, reduce artifacts, and visualize brain electrical activity through 3D source localization on an idealized head model. It helps clinicians understand brain activity over time by displaying quantitative trends, improving EEG assessment without providing diagnostic conclusions.

Second Opinion® 3D is an AI-powered software that helps dental professionals by automatically identifying and marking important anatomical structures in dental CBCT (Cone Beam Computed Tomography) radiographs. It highlights areas such as dentition, maxilla, mandible, and other key dental anatomical features, supporting clinicians to review images more efficiently and accurately. The software acts as a concurrent and second reader for patients aged 12 years or older, assisting in dental evaluation without replacing full clinical patient assessment.

The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.