# K261378: Rayvolve AZchest

- Pathway: 510(k) (Traditional)
- Applicant: AZmed
- Decided: Aug 28, 2026 after 123 days
- Product code: QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN180005 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260378: Rayvolve, AZmed (2026). Cleared while this submission was under review Summary page 6.

## Indications for use
Rayvolve AZchest is a radiological computer-assisted detection and diagnosis (CADe/x) software device that analyzes frontal chest radiographs for the presence of specific targeted pathologies within the Pleura, Mediastinum, and Parenchyma. Rayvolve uses deep learning techniques to detect, identify, and provide diagnostic outputs by labeling Regions of Interest (ROIs). The device highlights ROIs using bounding boxes for Pleural effusion, Consolidation and increased cardiothoracic ratio (CTR). For Pneumothorax, the device highlights ROIs using bounding boxes or contours to assist in the diagnosis of this condition. Detection of Pleural effusion, Pneumothorax, and increased CTR is indicated only for chest radiographs acquired in the erect or semi-erect positions. Detection of Consolidation is indicated for chest radiographs acquired in erect, semi-erect, or supine positions. Rayvolve AZchest is not indicated for the analysis of non-diagnostic images (e.g., due to severe motion artifacts or exposure issues). Rayvolve AZchest is intended for use as a second-reading aid for radiologists. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It does not replace the role of radiologists or of other diagnostic testing in the standard of care. Rayvolve AZchest is for prescription use only and is indicated for adult and pediatric patients (aged 18 years and older) only.

Source page: https://510kreport.com/device/K261378
Methodology: https://510kreport.com/methodology