# K243239: Lung AI (LAI001)

- Pathway: 510(k) (Traditional)
- Applicant: Exo, Inc.
- Decided: Apr 24, 2025 after 196 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: 3 generations back to P000041 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230085: Lung-CAD, Imagen Technologies, Inc. (2023) Summary page 5.

## Indications for use
Lung AI software device is a Computer-Aided Detection (CADe) tool designed to assist in the detection of consolidation/atelectasis and pleural effusion during the review of lung ultrasound scans. The software is an adjunctive tool to alert users to the presence of regions of interest (ROI) with consolidation/atelectasis and pleural effusion within the analyzed lung ultrasound cine clip. Lung AI is intended to be used on images collected from the PLAPS point, in accordance with the BLUE protocol. The intended users are healthcare professionals who are trained and qualified in performing lung ultrasound and routinely perform lung ultrasounds as part of their current practice in a point-of-care environment—namely Emergency Departments (EDs). The device was not designed and tested with use environments representing EMTs and military medics. Lung AI is not intended for clinical diagnosis and does not replace the healthcare provider’s judgment or other diagnostic tests in the standard care for lung ultrasound findings. All cases where a Chest CT scan and/or Chest X-ray is part of the standard of care should undergo these imaging procedures, irrespective of the device output. The software is indicated for adults only.

Source page: https://510kreport.com/device/K243239
Methodology: https://510kreport.com/methodology