FDA Radiology AI Devices

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

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 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.

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.

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.

TrueFit Bolus and TrueFlex Bolus are 3D printed patient-specific bolus accessories used in external beam radiation therapy to ensure accurate radiation dose delivery near the skin surface. Designed using patient imaging data, these devices improve treatment precision and patient comfort by compensating for tissue irregularities during cancer treatment.