FDA Radiology AI Devices

MAGNETOM Avanto fit and MAGNETOM Skyra fit are advanced MRI systems designed by Siemens that provide high-quality magnetic resonance imaging. These devices produce detailed cross-sectional images as well as spectroscopic data of the head, body, and extremities, helping physicians diagnose a variety of conditions and support imaging during interventional procedures with MR compatible devices.

Clarius Bladder AI is a software application integrated into the Clarius Ultrasound Scanner system that uses artificial intelligence to assist healthcare professionals in semi-automatically measuring bladder volume using ultrasound images. It automates bladder detection and measurement in both sagittal and transverse views but allows users to manually adjust results, facilitating efficient and accurate bladder volume assessment in adult patients.

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

MAGNETOM Free.Max and MAGNETOM Free.Star are magnetic resonance diagnostic devices produced by Siemens that generate high-quality MRI images of the head, body, or extremities in multiple planes. These systems assist clinicians in diagnosis and can be used during interventional procedures with MR-compatible tools. They incorporate advanced AI-powered features to enhance image quality and scanning efficiency.

BraveCX is an AI-based software that analyzes adult chest X-ray images to detect pleural effusion and pneumothorax. It helps radiologists prioritize cases with suspected critical findings by flagging suspicious images in the PACS worklist, enhancing workflow efficiency without providing direct diagnostic decisions.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

Contour ProtégéAI by MIM Software Inc. is a medical imaging software that assists trained medical professionals by automatically creating contours on CT and MR images using machine learning. It helps in radiation therapy by segmenting anatomical structures and specific tissues like the prostate and urethra from imaging data, improving efficiency and accuracy in treatment planning. The software works on multiple platforms and supports cloud or local deployment, allowing users to review and edit automated results for patient management and follow-up.

LOGIQ E10 is a general-purpose diagnostic ultrasound imaging system designed for use by qualified physicians. It supports multiple ultrasound modes such as B-mode, Doppler imaging, harmonic imaging, elastography, and 3D/4D imaging, providing digital image acquisition and processing. The system includes AI-powered features like Auto Renal Measure Assistant and Auto Abdominal Color Assistant to assist clinicians by automating measurements and suggesting anatomical views, thus improving workflow efficiency and diagnostic accuracy.

The LOGIQ E10s and LOGIQ Fortis are advanced general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. They provide high-resolution ultrasound imaging and measurements across a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, musculoskeletal, and intraoperative imaging. The systems incorporate various imaging modes such as Doppler, elastography, 3D/4D imaging, and AI-powered assistant features to enhance workflow and diagnostic accuracy, thereby assisting clinicians in evaluating and analyzing human body structures and fluids effectively.

Lunit INSIGHT DBT is an AI-powered software designed to assist physicians in detecting and characterizing suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) images. It analyzes DBT scans to identify and highlight regions of soft tissue lesions and calcifications with scores indicating malignancy likelihood, thereby supporting better screening and diagnosis of breast cancer in women.