# K201560: Auto Lung Nodule Detection

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Aug 31, 2021 after 447 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: 1 generation back to P000041 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P000041: Rapidscreen RS-2000, Riverain Medical Group (2001) Summary page 5.

## Most influential descendants
- K243831: Rayvolve LN (2025), 0 descendants of its own
- K231805: qXR-LN (2023), 0 descendants of its own
- K223133: VisiRad XR (2023), 0 descendants of its own

## Indications for use
The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.

Source page: https://510kreport.com/device/K201560
Methodology: https://510kreport.com/methodology