FDA Radiology AI Devices

Contour ProtégéAI is a medical imaging software accessory designed to assist trained medical professionals by automatically creating anatomical contours on CT and MR images using machine learning. It helps in radiation therapy planning by segmenting various body structures, including the prostate and pelvic organs, enabling quantitative analysis, adaptive therapy, and patient follow-up. Results generated by the AI can be reviewed and edited to ensure accuracy.

The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.

AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.

Annalise Enterprise CTB Triage Trauma is an AI-powered software that assists clinicians by automatically analyzing brain CT scans to identify signs of acute hemorrhages. It helps prioritize studies in the workflow to ensure patients with urgent findings are reviewed faster, improving triage and clinical efficiency. The system integrates with existing imaging management systems and does not provide standalone diagnostic decisions but supports clinicians in managing their workload.

The Butterfly iQ/iQ+ Ultrasound System is a portable, handheld ultrasound device that helps healthcare professionals visualize and measure anatomical structures and fluids in both adult and pediatric patients. It supports multiple clinical applications including lung, cardiac, abdominal, and musculoskeletal imaging. The system integrates AI-powered software called Auto B-line Counter that automatically detects and counts B-lines in lung ultrasound images, aiding clinicians in diagnosing and monitoring lung conditions.

Formus Hip is a preoperative planning software designed to assist orthopedic surgeons by automatically generating 3D models of the hip from CT scans and overlaying digital representations of hip implants. It uses AI algorithms for image segmentation and statistical shape modeling, helping clinicians plan hip replacement surgeries more effectively by customizing implant fitting interactively and producing printable surgical plans.

RayStation 12A by RaySearch Laboratories is a comprehensive radiation therapy treatment planning system that allows users to import patient images, define treatment targets, optimize and evaluate radiation treatment plans, and administer them. It supports multiple imaging modalities including CT, PET, and MR, enhancing precision in oncologic care by helping clinicians design effective and tailored radiation treatments while ensuring safety and accuracy.

DTX Studio Clinic 3.0 is an AI-powered software tool designed to assist dentists in detecting dental conditions such as caries, bone loss, periapical radiolucency, root canal filling deficiencies, discrepancy at the margin of restorations, and calculus from intraoral radiographs. It supports review of bitewing and periapical radiographs in patients aged 15 and older, providing highlighted areas of suspicion to aid clinical assessment and diagnosis.

MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.