# K211733: Lunit INSIGHT CXR Triage

- Pathway: 510(k) (Traditional)
- Applicant: Lunit, Inc.
- Decided: Nov 10, 2021 after 159 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: 4 generations back to DEN170073 (2018). 5 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192320: HealthCXR, Zebra Medical Vision, Ltd. (2019) Summary page 4.
- K183182: Critical Care Suite, Ge Medical Systems, LLC (2019) Summary page 4.

## Most influential descendants
- K230899: qXR-PTX-PE (2023), 1 descendant of its own
- K253751: CXRDetectAI (2026), 0 descendants of its own
- K243808: Rayvolve PTX-PE (2025), 0 descendants of its own
- K241439: VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (2024), 0 descendants of its own
- K232410: SmartChest (2024), 0 descendants of its own

## Indications for use
Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions 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/K211733
Methodology: https://510kreport.com/methodology