# K232410: SmartChest

- Pathway: 510(k) (Traditional)
- Applicant: Milvue
- Decided: May 10, 2024 after 274 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN170073 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211733: Lunit INSIGHT CXR Triage, Lunit, Inc. (2021) Summary page 4.

## Indications for use
SmartChest is a radiological computer assisted triage and notification software that analyzes frontal chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of transitional adolescents (18 - 21 yo but treated like adults) and adults (222 yo) for the presence of suspected pleural effusion and/or pneumothorax. SmartChest uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides case-level output available to a PACS (or other DICOM storage platforms) for worklist prioritization. As a passive notification for prioritization-only software tool within the standard of care workflow, SmartChest does not send a proactive alert directly to a trained medical specialist. SmartChest is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Source page: https://510kreport.com/device/K232410
Methodology: https://510kreport.com/methodology