FDA Radiology AI Devices

Saige-Dx (3.1.0) is an AI-based software designed to assist radiologists by analyzing digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications indicative of cancer. It evaluates 3D and 2D mammogram images, assigning suspicion levels for findings and cases, and produces reports to support concurrent reading. This helps clinicians improve detection accuracy and reduce reading time in breast cancer screening for women aged 35 and older.

MSKai is a medical software that helps clinicians by automatically identifying, measuring, and reporting features of the lumbar spine from T2 weighted MRI images. It supports radiologists and spine surgeons by providing reliable, repeatable quantitative assessments that can be reviewed and confirmed for clinical use, improving workflow efficiency.

The TOPAZ Mobile X-ray System by DRGEM Corporation is a portable X-ray machine designed to obtain high-quality digital radiographic images for patients who cannot be moved to the radiology department. It features a motorized drive mechanism for easy mobility, a flat panel digital detector for rapid image acquisition, and enhanced software for image processing. The system supports various flat panel detectors and includes a touchscreen interface to facilitate workflow, helping clinicians quickly and accurately examine patients in bed or other immobile settings.

The ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co., Ltd is a mobile diagnostic ultrasound system designed to assist qualified physicians in imaging and analyzing various parts of the human body and fluids. It supports multiple clinical applications including abdominal, fetal/obstetrics, gynecology, cardiac, vascular, musculoskeletal, and pediatric imaging with advanced imaging modes like 3D/4D, Doppler, elastography, and contrast imaging. The system provides high-quality ultrasound imaging and measurement capabilities intended for hospitals and clinics to enhance diagnostic confidence and patient management.

The uMI Panvivo is a PET/CT medical imaging system designed to provide combined anatomical and functional images for clinicians. It uses PET to show distribution of radiopharmaceuticals and CT to provide detailed anatomical information. The system supports assessment of metabolic and physiologic functions across various parts of the body including oncology, neurology, and infection imaging. It can also assist in treatment planning for radiotherapy and interventional radiology, improving diagnostic accuracy and patient care.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips are advanced ultrasound imaging systems used for a wide range of diagnostic applications across many body regions. The newly introduced Auto ElastQ software feature assists clinicians by automatically selecting the most stable frames and regions of interest for liver stiffness measurements with 2D shear wave elastography, making the diagnostic workflow easier and potentially more reliable. This helps healthcare professionals to assess liver tissue characteristics more efficiently during ultrasound exams.

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

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.

IRISeg is a software application developed by Intuitive Surgical that utilizes machine learning to assist with the segmentation of contrast-enhanced kidney CT scans and generates 3D models for preoperative surgical planning and intraoperative display. It provides both automatic and manual tools to segment kidney structures, helping clinicians visualize anatomy more efficiently and accurately for better patient management.

The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.