# K242919: V5med Lung AI

- Pathway: 510(k) (Traditional)
- Applicant: V5med, Inc.
- Decided: Mar 27, 2025 after 184 days
- Product code: OEB (Lung Computed Tomography System, Computer-Aided Detection)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221592: AVIEW Lung Nodule CAD, Coreline Soft Co., Ltd. (2023) Summary page 5.
- K161201: ClearRead CT, Riverain Technologies, LLC (2016) Summary page 5.

## Indications for use
V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the AI analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung AI does not replace the radiologist's critical judgment or diagnostic processes and should not be used in isolation from the original CT series.

Source page: https://510kreport.com/device/K242919
Methodology: https://510kreport.com/methodology