FDA Radiology AI Devices

SpectoMed (v1.0) is a software tool for medical professionals that enables real-time 3D visualization and analysis of CT and MRI images. It supports virtual and augmented reality interfaces to aid clinicians in preoperative planning and during surgery by providing realistic spatial views of patient anatomy along with measurement tools, enhancing diagnostic assessment and surgical preparation.

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.

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 Eclipse Treatment Planning System (version 18.1) is a software tool designed by Varian Medical Systems to assist clinicians in planning radiation therapy for patients with malignant or benign diseases. It uses medical imaging to create a virtual patient model to simulate and optimize radiation dose distributions for external beam and internal radiation treatments, ensuring effective tumor targeting while minimizing damage to healthy tissues. This system includes features for proton therapy and advanced optimization algorithms to enhance treatment quality and delivery efficiency.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

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.

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.

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.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.