# K243831: Rayvolve LN

- Pathway: 510(k) (Traditional)
- Applicant: AZmed
- Decided: Mar 26, 2025 after 103 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P000041 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201560: Auto Lung Nodule Detection, Samsung Electronics Co., Ltd. (2021) Summary page 7.

## Indications for use
Rayvolve LN is a computer-aided detection software device to assist radiologists to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30mm size. It is designed to aid radiologists in reviewing the frontal (AP/PA) chest radiographs of patients of 18 years of age or older acquired on digital radiographic systems as a second reader and be used with any DICOM Node server. Rayvolve LN provides adjunctive information only and is not a substitute for the original chest radiographic image.

Source page: https://510kreport.com/device/K243831
Methodology: https://510kreport.com/methodology