FDA Radiology AI Devices

The Radiography 7300 C by Philips Medical Systems DMC GmbH is a stationary X-ray imaging system designed to capture high-quality radiographic images. It assists clinicians by providing detailed X-ray images that are essential for diagnosing various medical conditions involving the chest, bones, abdomen, and other body areas.

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.

YSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

Overjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.

Overjet Charting Assist is an AI-powered medical image processing system that helps dental professionals detect and identify dental structures such as teeth anatomy and past restorative treatments on various dental radiographs. It assists in creating dental charts more efficiently by analyzing bitewing, periapical, and panoramic images, helping reduce manual charting efforts by over 80%.

CEPHX is a software tool designed for orthodontists that uses AI to analyze cephalometric x-ray images. It automatically identifies important anatomical landmarks on 2D x-rays, aiding in diagnosis, treatment planning, and patient consultation for individuals over 14 years old. This helps clinicians effectively monitor and simulate orthodontic treatment progress.

Radify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.

VEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.

qXR-LN is an AI-based software device that analyzes frontal chest X-rays to detect and mark suspected lung nodules between 6 and 30 mm. It acts as a second reader to assist physicians like radiologists and pulmonologists, providing adjunctive information to improve detection accuracy without substituting the original image or clinical judgment.