FDA Radiology AI Devices

The TOPAZ Mobile X-ray System by DRGEM Corporation is a portable X-ray machine designed to obtain high-quality digital radiographic images for patients who cannot be moved to the radiology department. It features a motorized drive mechanism for easy mobility, a flat panel digital detector for rapid image acquisition, and enhanced software for image processing. The system supports various flat panel detectors and includes a touchscreen interface to facilitate workflow, helping clinicians quickly and accurately examine patients in bed or other immobile settings.

The ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co., Ltd is a mobile diagnostic ultrasound system designed to assist qualified physicians in imaging and analyzing various parts of the human body and fluids. It supports multiple clinical applications including abdominal, fetal/obstetrics, gynecology, cardiac, vascular, musculoskeletal, and pediatric imaging with advanced imaging modes like 3D/4D, Doppler, elastography, and contrast imaging. The system provides high-quality ultrasound imaging and measurement capabilities intended for hospitals and clinics to enhance diagnostic confidence and patient management.

Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.

Anterion is a non-contact ophthalmic imaging device that uses swept-source optical coherence tomography (SS-OCT) to visualize and measure the anterior segment of the eye, including corneal thickness, anterior chamber parameters, lens thickness, and axial length. It helps clinicians by providing detailed tomographic images and quantitative metrics critical for diagnosis and surgical planning, such as cataract surgery. The device includes multiple software applications for imaging and analysis and uses AI-powered processing for precise measurements, improving clinical decision-making and patient management.

Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.

The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.

The uMI Panvivo is a PET/CT medical imaging system designed to provide combined anatomical and functional images for clinicians. It uses PET to show distribution of radiopharmaceuticals and CT to provide detailed anatomical information. The system supports assessment of metabolic and physiologic functions across various parts of the body including oncology, neurology, and infection imaging. It can also assist in treatment planning for radiotherapy and interventional radiology, improving diagnostic accuracy and patient care.

Mac-Lab (AltiX AI.i), CardioLab (AltiX AI.i), ComboLab (AltiX AI.i), and MLCL Client Software (AltiX AI.i) are hemodynamic and electrophysiology recording systems developed by GE Healthcare. These systems record and display physiological data during cardiovascular procedures, allowing clinicians to analyze hemodynamic and electrophysiology signals in real time. The MLCL Client Software allows additional data analysis and remote viewing. These tools help doctors monitor and analyze patients' cardiovascular function during interventional procedures.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips are advanced ultrasound imaging systems used for a wide range of diagnostic applications across many body regions. The newly introduced Auto ElastQ software feature assists clinicians by automatically selecting the most stable frames and regions of interest for liver stiffness measurements with 2D shear wave elastography, making the diagnostic workflow easier and potentially more reliable. This helps healthcare professionals to assess liver tissue characteristics more efficiently during ultrasound exams.

The Infrascanner Model 2500 is a noninvasive medical device designed to help detect traumatic brain hematomas in patients with head injuries. It uses near-infrared light to measure differences in hemoglobin concentration in the brain, which indicate the presence of hematomas. The device aids clinicians in quickly assessing patients for further CT scans, improving early diagnosis and treatment in hospital settings.