FDA Radiology AI Devices

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.

Second Opinion CC is a specialized AI software designed to assist dental professionals in identifying dental caries on bitewing and periapical radiographs. It processes dental X-ray images and highlights potential caries regions using polygonal contours, helping clinicians review images more effectively as a second reader without replacing their clinical judgment.

Ortho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.

IQ-UIP is an AI-powered computer-aided software designed to analyze non-contrast chest CT scans to detect and notify specialists about radiological findings suggestive of usual interstitial pneumonia (UIP), a type of fibrotic lung disease. It works alongside standard radiological workflows to help clinicians by providing summarized findings via a worklist application, assisting in the evaluation of interstitial lung disease without altering original images or providing diagnostic conclusions itself.

Saige-Dx (3.1.0) is an AI-based software designed to assist radiologists by analyzing digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications indicative of cancer. It evaluates 3D and 2D mammogram images, assigning suspicion levels for findings and cases, and produces reports to support concurrent reading. This helps clinicians improve detection accuracy and reduce reading time in breast cancer screening for women aged 35 and older.

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 Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.

Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.