FDA Radiology AI Devices

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

The Notal Vision Home OCT System is an AI-based home use device that enables patients with neovascular age-related macular degeneration (NV-AMD) to self-image their eyes at home using Optical Coherence Tomography (OCT). It captures detailed images of the retina, segments and quantifies hypo-reflective spaces associated with fluid build-up, and securely transmits data for physician review between scheduled clinic visits. This allows more frequent monitoring of eye disease progression without replacing standard clinical examinations.

BriefCase-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

DeepContour (V1.0) is a software tool that uses deep learning to automatically segment organs on CT images for radiation therapy planning. It helps trained healthcare professionals by generating and editing organ contours, performing 3D reconstruction, and analyzing anatomical structures. By automating these tasks, it improves workflow efficiency and supports precise radiation treatment planning.

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.

Ethos Treatment Management 3.0 and Ethos Treatment Planning 2.0 from Varian Medical Systems are software applications designed to assist clinicians in managing, generating, and modifying radiation therapy treatment plans. They incorporate AI-based segmentation algorithms to aid in contouring anatomical structures to improve and streamline radiation therapy planning and monitoring. These tools help improve accuracy and efficiency in radiation treatment for cancer and other diseases requiring radiation therapy.

ARVIS® Shoulder is a computer-assisted surgical navigation system designed to help surgeons precisely position and align implants during total shoulder arthroplasty. It uses preoperative CT scans processed with AI algorithms for automatic image segmentation and anatomical landmark identification, providing real-time measurements during surgery to guide instrument placement and implant positioning, thereby enhancing surgical accuracy and outcomes.

syngo.via RT Image Suite is a software tool designed to assist clinicians in viewing, manipulating, and contouring 3D and 4D medical images from various modalities such as CT, PET, MRI, and CBCT. It helps prepare radiation therapy treatment plans by enabling visualization, semi-automatic and automatic contouring of tumors and organs, image registration, and image fusion. The software improves workflow efficiency and treatment accuracy in radiation oncology.