Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.
Intended Use
Computer-aided detection software device to assist radiologists in identifying and marking regions related to suspected pulmonary nodules from 6 to 30 mm in size on frontal chest radiographs of patients 18 years or older acquired on digital radiographic systems as a second reader.
Technology
Standalone software using deep learning techniques to detect and localize pulmonary nodules on chest X-rays. It uses the DICOM image standard for data input/output, can interact with DICOM Node servers (e.g. PACS), and supports AP and PA views. Intended as an aided-diagnosis device and not autonomous.
Performance
Software verification and validation confirmed conformance to design specifications; standalone testing on 2181 radiographs showed nodule detection with sensitivity ~0.88, specificity ~0.83, and AUC ~0.84. Clinical multi-reader study showed reader diagnostic accuracy improved significantly when aided by Rayvolve LN, with reader AUC rising from 0.807 to 0.858, sensitivity and specificity also improved.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2024
3 months - 2
FDA Approval
3/26/2025
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