FDA Radiology AI Devices

SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.

The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

The Nanox.ARC is a stationary, stand-alone digital tomosynthesis X-ray system designed to produce tomographic images of various body regions like musculoskeletal system, lungs, abdomen, and paranasal sinuses. It aids clinicians by providing 3D-like images synthesized from multiple low-dose X-ray images taken during a single sweep, helping reduce overlap of structures and improving diagnostic accuracy. The system is intended for use by trained radiologists and technologists in hospitals and imaging centers for adult patients.

DeepRhythmAI is a cloud-based AI software that analyzes two-lead ECG data to detect cardiac arrhythmias in adult patients. It integrates with ambulatory ECG devices like Holter monitors and cardiac telemetry systems to help healthcare professionals review and confirm arrhythmia diagnoses, providing supportive information alongside clinical knowledge.

The Rextar Pro is a portable, handheld extraoral X-ray device designed for use by trained dentists and dental technicians to produce diagnostic X-ray images using intraoral image receptors. It is a battery-powered high-frequency X-ray generator with specialized shielding to minimize radiation exposure to users. This lightweight and compact device helps clinicians obtain high-quality dental images conveniently and safely.

XBeam (v2) is a software tool designed to calculate and validate the radiation dose or monitor units needed during external beam radiation therapy. It supports treatment planning for superficial and orthovoltage radiotherapy systems made by Xstrahl. By accurately calculating treatment parameters like beam-on time and dose, it helps ensure patients receive the prescribed radiation safely and accurately. The software is intended for use by trained medical physics professionals to improve the quality assurance of radiation treatments.

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used to visualize and analyze structures within the human body. They support diverse clinical applications including obstetrics, cardiology, abdominal imaging, and musculoskeletal imaging through multiple ultrasound modes such as 2D, Doppler, and 3D/4D. The systems incorporate AI technologies to assist clinicians in fetal biometry and cardiac view recognition, helping improve diagnostic accuracy and workflow efficiency.

Sonix Health is a software product designed to analyze echocardiography ultrasound images automatically. It helps clinicians by classifying ultrasound views and measuring cardiac parameters using AI, thereby improving efficiency and accuracy in heart assessment for adult patients.