FDA Radiology AI Devices

The SPECTRALIS HRA+OCT and variants by Heidelberg Engineering GmbH are non-contact ophthalmic imaging devices combining confocal laser-scanning ophthalmoscopy and spectral-domain optical coherence tomography (SD-OCT). They capture detailed cross-sectional and angiographic images of the eye, aiding clinicians in diagnosing and managing various ocular diseases such as macular degeneration, diabetic retinopathy, and glaucoma. These devices enhance visualization of ocular anatomy and vascular structures, improving clinical evaluation and patient care.

The P-Cure Proton Therapy System (PPTS) is a medical device that produces and delivers proton beam radiation to treat patients with localized tumors and conditions in the head, neck, and thorax. It improves treatment accuracy by using advanced image-guided and robotic patient positioning, including CT and X-ray imaging, helping clinicians precisely target tumors while minimizing damage to surrounding tissues.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a medical device designed to image the inside of coronary and peripheral blood vessels using ultrasound. It provides real-time cross-sectional images to help clinicians evaluate vessel morphology as an adjunct to angiography, aiding in diagnosis and treatment planning for cardiovascular conditions.

The CT/MR Tandem and Ovoid Set by Varian Medical Systems is a gynecological brachytherapy applicator that is used to treat cancers of the uterus, cervix, paracervix, endometrium, and vagina via HDR brachytherapy. The device is designed to be compatible with CT and MRI imaging, helping clinicians accurately deliver radioactive sources for cancer treatment. It improves patient care by ensuring precise radiation placement and is safe for MR environments.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.

The VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.

The SKOUT system is an AI-powered software device that helps gastroenterologists detect potential colorectal polyps in real-time during colonoscopy procedures. It highlights suspected polyps on the endoscopic video feed to assist doctors in colorectal cancer screening and surveillance, improving detection accuracy without replacing clinical judgment.

Second Opinion BLE is a software tool that uses AI to help dental professionals measure bone levels in bitewing and periapical radiographs. It assists clinicians by automatically detecting and displaying bone level measurements to aid in patient assessment, but it is not intended to replace full clinical evaluation.

The Volta AF-Xplorer is a medical device that uses machine and deep learning algorithms to help clinicians annotate 3D anatomical and electrical maps of the human heart in real-time. It primarily assists in identifying regions within the atria that exhibit abnormal electrical activity during atrial fibrillation or atrial tachycardia, which can guide targeted catheter ablation procedures, improving patient outcomes.

The Ultrasound Imaging System (LU700, 128, and LX Series) by Leltek Inc. is a portable, software-controlled ultrasound system that runs on commercial mobile devices. It uses wireless transducers communicating over Wi-Fi to acquire and display real-time, high-resolution ultrasound images across multiple modes such as B-mode and Doppler modes. It aids clinicians in evaluating various body regions and conditions by providing versatile imaging capabilities tailored for different probes and clinical applications.