FDA Radiology AI Devices

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.

The RemedyLogic AI MRI Lumbar Spine Reader is a software tool that automatically analyzes MRI images of the lumbar spine to identify and measure anatomical features. It helps radiologists and spine surgeons by providing quantitative measurements and image segmentations, which can improve the efficiency and accuracy of their analyses and reporting. Users review and adjust the software's outputs before finalizing diagnostic or treatment decisions.

The Symbia Pro.specta VA30A Family by Siemens is a hybrid SPECT/CT imaging system designed for healthcare professionals to help detect, localize, diagnose, and monitor various diseases including cardiovascular, neurological disorders, and cancer. It combines physiological imaging from SPECT with anatomical imaging from CT, enabling accurate assessment and radiotherapy planning. The device also supports low dose lung cancer screening and advanced image analysis software to assess and quantify pathologies.

VistaPano S Ceph 2.0 and related models are advanced 2-in-1 digital X-ray imaging systems designed to capture detailed panoramic and cephalometric images of the dento-maxillofacial region, sinus, and TMJ for adult and pediatric patients. It supports orthodontic treatment by also using carpal images. The systems are intended to be operated by medical professionals such as dentists, physicians, and x-ray technicians, improving diagnostic capabilities in dental and maxillofacial care.

The LCD Monitors C310S, G310S, C316S, G316S, and C616W by Shenzhen Beacon Display Technology Co.,Ltd. are high-resolution, calibrated diagnostic displays specifically designed for radiology. These monitors support the viewing and analysis of digital images such as X-rays and MRIs, helping clinicians review and diagnose patient conditions accurately. They incorporate advanced LED backlighting, brightness stabilization, and anti-glare screens to ensure image clarity and consistency, crucial for precise medical evaluation.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

TumorSight Viz is a cloud-based AI software that helps clinicians visualize and analyze breast MRI images in patients with early-stage or locally advanced breast cancer. It processes dynamic contrast-enhanced MRI data to provide 3D renderings, measurements, and segmentations of tumors, supporting more informed clinical evaluations and treatment planning.

The Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging is a portable, software-controlled ultrasound system designed for real-time visualization of anatomical structures and blood flow using B-mode, color Doppler, and pulsed wave imaging. It aids healthcare professionals by providing detailed imaging and fluid flow analysis across multiple body regions such as abdominal, musculoskeletal, and vascular areas, facilitating diagnosis at the point of care.

The ROCC Console is a software system that enables remote control, support, and standardization of medical imaging protocols, particularly for MR and CT scanners. It helps technologists and medical personnel operate scanners remotely and manage imaging protocols, improving workflow and access to expertise without requiring physical presence on site.

MIM – Symphony HDR Fusion is an advanced medical imaging software designed to assist trained clinicians with processing and analyzing multiple imaging modalities such as CT, MRI, PET, and ultrasound. It supports fusion and registration of images, contouring of tumors and tissues, and planning for high dose rate brachytherapy treatments. By integrating image visualization, catheter digitization, and dose planning, it helps clinicians optimize radiation therapy for cancer patients safely and effectively.