FDA Radiology AI Devices

The Biograph Vision and Biograph mCT PET/CT systems by Siemens are advanced imaging devices combining positron emission tomography (PET) and computed tomography (CT). These systems help clinicians detect and diagnose various conditions by providing detailed molecular and anatomical images, facilitating better patient management.

The ARTIS icono (VE40A) family and ARTIS pheno (VE40A) are advanced angiography systems that enable detailed imaging for diagnostic and interventional procedures. They support single-plane and biplane imaging with a motorized C-arm and flat panel detector, allowing clinicians to perform cardiac, neuro, general angiography, and image-guided surgeries. The systems provide 2D and 3D imaging capabilities, including 3D reconstruction software (DynaCT), which helps clinicians visualize both hard and soft tissues for diagnosis, surgical planning, and treatment follow-up.

The ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.

The NAEOTOM Alpha is a dual-source computed tomography (CT) scanner developed by Siemens Medical Solutions. It uses advanced photon-counting detector technology and incorporates AI-driven image reconstruction and post-processing software to produce highly detailed cross-sectional images. This device assists trained clinicians in diagnosing and treating patients, including applications like low-dose lung cancer screening in high-risk populations. It features enhanced workflow tools, integrated needle guidance for interventions, and supports sophisticated quantitative imaging techniques.

MAGNETOM Terra and MAGNETOM Terra.X are advanced 7 Tesla MRI systems by Siemens designed for capturing high-quality magnetic resonance images primarily of the head and extremities. Equipped with enhanced hardware and AI-based software (Deep Resolve Boost, Sharp, and RxE), these devices improve image quality and reconstruction speed, helping radiologists obtain clearer diagnostic images faster, thus supporting better patient diagnosis and care.

MAGNETOM Cima.X Fit is a magnetic resonance imaging (MRI) system by Siemens that produces detailed cross-sectional images of the body, head, or extremities. It incorporates AI-driven software features to enhance image quality and accelerate scanning, helping clinicians diagnose by providing clearer and faster MRI scans.

MAGNETOM Sola and MAGNETOM Altea are advanced MRI systems designed to produce high-quality transverse, sagittal, coronal, and oblique cross-sectional images. They include AI-powered features such as Deep Resolve Boost and Deep Resolve Sharp for enhanced image reconstruction, improving image quality and diagnostic accuracy. These systems assist clinicians in diagnosis by providing improved visualization of internal structures and functions across the head, body, and extremities, and can also be used during MR-guided interventional procedures.

MAGNETOM Cima.X is an advanced magnetic resonance imaging (MRI) system designed to produce detailed images and spectroscopic data of the head, body, and extremities. It incorporates new and modified hardware and software features including deep learning-based reconstruction methods to enhance image quality and speed, helping clinicians in diagnosis and interventional imaging procedures.

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.

The MAGNETOM Vida, Lumina, Aera, Skyra, Prisma, and Prisma fit are advanced magnetic resonance imaging (MRI) systems designed to produce detailed cross-sectional and spectroscopic images of the body, head, and extremities. Equipped with new hardware and software improvements including AI-based image reconstruction techniques, these systems help clinicians obtain high-quality images to assist in diagnosis and interventional procedures.