FDA Radiology AI Devices

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

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 ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient outcomes.

The SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option is a computed tomography (CT) X-ray system developed by Arineta Ltd. It produces detailed cross-sectional images of the body, especially of the cardiovascular and thoracic areas, enabling clinicians to screen and diagnose lung cancer using low-dose CT protocols. This device helps physicians detect lung nodules and other thoracic abnormalities with reduced radiation exposure, supporting effective lung cancer screening programs following clinical guidelines.

The NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.

PeriCALM Patterns 3.0 is an AI-based software tool designed to assist clinicians in monitoring fetal well-being during pregnancy and labor. It analyzes fetal heart rate and uterine contraction signals, automatically identifying patterns such as accelerations, decelerations, baseline heart rate, and contractions. This information supports clinical decision-making for pregnant patients at or beyond 32 weeks of gestation by providing annotated summaries of the fetal monitor recordings.

The INTRABEAM (700) system by Carl Zeiss Meditec AG is a mobile radiation therapy device designed to deliver targeted low-energy X-ray radiation during intraoperative, intracavity, interstitial, and contact radiotherapy treatments of tumors or tumor beds. It includes accessories such as a SMART Stand, spherical applicators for precise radiation delivery, and a sizer set to assist in applicator selection. The system aids clinicians by providing controlled radiation doses directly at the tumor site during surgery, potentially improving cancer treatment efficacy while sparing surrounding healthy tissue.

ScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.

The Dental Cone-beam Computed Tomography (FinScan F350) is an imaging system designed for dental and maxillofacial diagnostic support. It uses cone-beam CT technology along with panoramic and cephalometric X-ray imaging to produce detailed images of the dento-maxillofacial and TMJ structures, aiding dentists and health professionals in diagnosis, including assessment of growth and maturity for orthodontic treatment.