FDA Radiology AI Devices

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

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.

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.

RadUnity (Version 1.0.0) is a software device designed to centralize, manage, standardize, and network CT images using the DICOM protocol. It reformats CT medical images according to user-defined preferences to ensure consistent image formatting, thus supporting qualified radiology professionals in preparing images for interpretation. It is not intended for primary diagnostic review nor for mammographic image interpretation.

MROpen Evo is a whole body MRI diagnostic device designed to produce high-resolution images of various body structures in multiple orientations, including brain examination with DWI sequence. It facilitates imaging for patients who might benefit from standing scans or have movement disorders, and incorporates advanced software features like Compressed Sensing for faster image acquisition. The device uses superconducting magnets cooled by a cryocooler and is intended for diagnostic imaging with certain limitations in cardiac, breast, lung, and upper abdominal imaging.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.

The SKR 3000 is a digital X-ray imaging system designed to replace traditional film/screen radiography in general diagnostic radiographic procedures. It uses an advanced flat-panel detector with antibacterial properties and wireless communication capabilities to capture detailed digital images of the human body, helping clinicians efficiently obtain and manage diagnostic images. This system is intended for adult use and excludes applications like mammography, fluoroscopy, and angiography.

Jazz Classic is a dental imaging software that helps dental professionals capture, process, store, and review diagnostic dental images from various devices including intraoral x-ray sensors and scanners. It runs on standard PC hardware and assists clinicians in diagnosis and treatment planning by allowing image enhancement, annotation, and secure image management. This software supports both pediatric and general populations and integrates with dental practice management systems for improved workflow.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.