FDA Radiology AI Devices

Mobius3D (4.1) is a software tool designed for radiation therapy clinics to perform quality assurance, treatment plan verification, and patient alignment analysis. It calculates three-dimensional radiation dose distributions based on treatment plans and imaging data, helping clinicians verify and ensure accurate radiation therapy without directly interacting with the delivery system or patients.

The Spectral CT system by Philips is an advanced CT scanner that acquires dual-energy X-ray data to provide detailed cross-sectional images of the body. This technology enables the analysis of different materials' chemical composition and improves visualization of anatomical and pathological structures, aiding clinicians in diagnostic imaging and treatment planning across multiple clinical areas including radiology, cardiology, and oncology.

Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.

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 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 Altus Spine Navigation System is a set of reusable surgical instruments designed to assist surgeons in accurately placing pedicle screws during spinal surgery. It works together with a navigation system that uses medical images like CT or MRI scans to help locate anatomical landmarks, improving precision in both open and minimally invasive procedures. This system helps enhance surgical accuracy and patient safety by guiding screw placement in the spine.

LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.

The Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.

The Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd. is designed for dental and maxillofacial imaging using cone beam CT technology. It produces detailed 3D images of patients' oral and maxillofacial regions to assist clinicians in diagnosis and treatment planning, improving patient care in dental and maxillofacial medicine.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.