FDA Radiology AI Devices

SpineAR SNAP is a software device that helps surgeons plan and perform spinal implant surgeries more accurately by transforming traditional 2D medical images into interactive 3D visualizations. It supports pre-operative planning on screens and virtual reality, as well as intra-operative guidance using augmented reality headsets like HoloLens2 and Magic Leap 1. This technology provides enhanced visualization and guidance, improving surgical precision while allowing the surgeon to maintain focus on the surgical field.

Noxturnal Web is a web-based software designed to display, analyze, and manually score pre-recorded physiological data collected during sleep studies. It assists clinicians in diagnosing sleep and respiratory-related disorders by enabling detailed review and reporting of sleep stages and breathing events such as obstructive apneas, all under clinical supervision.

The Adora DRFi is a ceiling suspended, universal X-ray system designed for diagnostic radiography and fluoroscopy. It supports a wide range of whole-body X-ray examinations in both adult and pediatric patients and features a flat panel detector for direct radiography and radioscopy. The system improves ergonomics and workflow while enabling imaging in various patient positions including supine, standing, sitting, wheelchair, or stretcher. It is intended for use by trained healthcare professionals and is not for mammography.

Aquilion ONE (TSX-308A/3) V1.5 is a whole-body multi-slice helical CT scanner capable of imaging entire organs in a single rotation. It uses AI-powered deep learning reconstruction and noise reduction algorithms to enhance image quality, reduce radiation dose, and minimize artifacts. This helps clinicians obtain clearer diagnostic images for various body regions including the head, chest, abdomen, pelvis, cardiac, extremities, and lungs, supporting better patient diagnosis and treatment planning.

The NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

PanopticAI Vital Signs is a medical software application that uses AI algorithms to measure pulse rate non-invasively by analyzing color changes in facial video captured from an iPhone or iPad camera. It helps healthcare professionals monitor a patient's pulse rate remotely, providing a convenient tool to complement traditional vital sign assessments.

The aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.

The InkSpace Imaging Small Body Array is a flexible, receive-only MRI coil designed for use with Siemens 1.5T MRI systems. It helps capture high-quality diagnostic images of various body parts such as the heart, spine, joints, and prostate, assisting physicians and radiologists in making accurate diagnoses. The coil's flexible design improves patient comfort and scanning convenience.

Lightning Viewer is a web-based medical image viewing software that allows healthcare professionals to review, manipulate, and annotate diagnostic images from various modalities. It supports major desktop browsers, offers advanced visualization tools like 3D MPR and MIP, and integrates with PACS systems to facilitate efficient radiology workflows and aid clinicians in making diagnostic decisions.

The Voluson Expert Series (including models 18, 20, and 22) by GE Healthcare is a range of advanced ultrasound imaging systems designed for use by trained healthcare professionals in hospitals and clinics. They provide high-performance real-time ultrasound imaging and analysis capabilities including 2D, 3D, 4D, color Doppler, power Doppler, pulse wave Doppler, harmonic imaging, elastography, and advanced AI-assisted software for obstetric and gynecologic assessments. This helps clinicians obtain detailed diagnostic images for fetal, abdominal, cardiac, musculoskeletal, and other clinical applications, supporting accurate diagnosis and patient care.