FDA Radiology AI Devices

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 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.

The Digital Radiography X-ray System by Shenzhen SONTU Medical Imaging Equipment Co. is a modular digital X-ray system used in hospitals and clinics. It produces high-quality digital images of the whole body, including skull, chest, abdomen, and extremities, helping clinicians diagnose a wide range of conditions. The system supports various patient positions and utilizes digital detectors to convert X-rays into image signals quickly and accurately, enhancing clinical workflow and patient care.

Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.

Aquilion ONE (TSX-308A/3) V1.5 is a whole-body multi-slice helical CT scanner capable of imaging entire organs in a single rotation. It uses AI-powered deep learning reconstruction and noise reduction algorithms to enhance image quality, reduce radiation dose, and minimize artifacts. This helps clinicians obtain clearer diagnostic images for various body regions including the head, chest, abdomen, pelvis, cardiac, extremities, and lungs, supporting better patient diagnosis and treatment planning.

The NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

The Eclipse Treatment Planning System (version 18.1) is a software tool designed by Varian Medical Systems to assist clinicians in planning radiation therapy for patients with malignant or benign diseases. It uses medical imaging to create a virtual patient model to simulate and optimize radiation dose distributions for external beam and internal radiation treatments, ensuring effective tumor targeting while minimizing damage to healthy tissues. This system includes features for proton therapy and advanced optimization algorithms to enhance treatment quality and delivery efficiency.

The Nanox.ARC is a stationary, stand-alone digital tomosynthesis X-ray system designed to produce tomographic images of various body regions like musculoskeletal system, lungs, abdomen, and paranasal sinuses. It aids clinicians by providing 3D-like images synthesized from multiple low-dose X-ray images taken during a single sweep, helping reduce overlap of structures and improving diagnostic accuracy. The system is intended for use by trained radiologists and technologists in hospitals and imaging centers for adult patients.

The Rextar Pro is a portable, handheld extraoral X-ray device designed for use by trained dentists and dental technicians to produce diagnostic X-ray images using intraoral image receptors. It is a battery-powered high-frequency X-ray generator with specialized shielding to minimize radiation exposure to users. This lightweight and compact device helps clinicians obtain high-quality dental images conveniently and safely.

MROpen Evo is a whole body MRI diagnostic device designed to produce high-resolution images of various body structures in multiple orientations, including brain examination with DWI sequence. It facilitates imaging for patients who might benefit from standing scans or have movement disorders, and incorporates advanced software features like Compressed Sensing for faster image acquisition. The device uses superconducting magnets cooled by a cryocooler and is intended for diagnostic imaging with certain limitations in cardiac, breast, lung, and upper abdominal imaging.