# K241620: ChestView US

- Pathway: 510(k) (Traditional)
- Applicant: Gleamer Sas
- Decided: Feb 27, 2025 after 267 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.
1 later device descends from it; 1 cites 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)
- K213353: Aorta-CAD, Imagen Technologies, Inc. (2022) Summary page 5.

## Most influential descendants
- K252486: ChestView US (1.1) (2026), 0 descendants of its own

## Indications for use
ChestView US is a radiological Computer-Assisted Detection (CADe) software device that analyzes frontal and lateral chest radiographs of patients presenting with symptoms (e.g. dyspnea, cough, pain) or suspected for findings related to regions of interest (ROIs) in the lungs, airways, mediastinum/hila and pleural space. The device uses machine learning techniques to identify and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings : Nodule, Pleural space abnormality, Mediastinum/Hila abnormality, and Consolidation . ChestView is intended for use as a concurrent reading aid for radiologists and emergency medicine physicians. It does not replace the role of radiologists and emergency medicine physicians or of other diagnostic testing in the standard of care. ChestView is for prescription use only and is indicated for adults only.

Source page: https://510kreport.com/device/K241620
Methodology: https://510kreport.com/methodology