FDA Radiology AI Devices

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 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 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.

ApolloHipX is a software system designed to aid surgeons during Total Hip Replacement by precisely measuring the position and alignment of hip replacement components using radiological images. It integrates pre-operative 3D patient data with intra-operative 2D X-ray images to provide near-real-time assistive measurements, helping ensure the implants are correctly positioned relative to the patient's bone structures.

The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.

The GXR-Series Diagnostic X-Ray System by DRGEM Corporation is a stationary X-ray system designed for medical professionals to capture human anatomical images using X-rays. The system includes various device models with features like automatic calibration, digital flat panel detectors for direct radiography, and advanced image processing software to enhance image quality and workflow efficiency. It helps clinicians by providing high-quality radiographic images for diagnostic purposes while optimizing exposure settings and reducing downtime through remote system diagnosis.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system designed to produce detailed cross-sectional images of the head or body. It incorporates AI-based deep learning technology, called the Precise IQ Engine (PIQE), which enhances image resolution, reduces artifacts, and maintains or improves image quality. This helps clinicians obtain clearer and more precise images for diagnosis without additional scan time or parameters adjustment.

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.