Lunit INSIGHT CXR Triage
K211733Lunit Inc. · cleared 2021-11-10 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“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).”
AlgorithmAI-based image analysis algorithms
source quote (p.5)
“Lunit INSIGHT CXR Triage is a radiological computer-assisted prioritization software that utilizes AI-based image analysis algorithms to identify pre-specified critical findings (pleural effusion and/or pneumothorax) on frontal chest X-ray images and flag the images in the PACS/workstation to enable prioritized review by the appropriately trained medical specialists who are qualified to interpret chest radiographs.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Standalone
n=1,385 images
endpoints: ROC AUC; sensitivity; specificity
Retrospective clinical
n=1,708 images
endpoints: ROC AUC; sensitivity; specificity
Reported performance (6 observations)
sensitivity0.8986CI [86.72, 93.00]
source quote (p.7)
“sensitivity 89.86% (95% CI: 86.72 - 93.00)”
specificity0.9348CI [91.06, 95.91]
source quote (p.7)
“specificity 93.48% (95% CI: 91.06 - 95.91)”
aurocas written: “auc”0.9686CI [0.9547, 0.9824]
source quote (p.7)
“ROC AUC 0.9686 (95% CI: 0.9547 - 0.9824)”
sensitivityas written: “Sensitivity for pneumothorax”0.8892CI [85.60, 92.24]
source quote (p.7)
“Sensitivity 88.92% (95% CI: [85.60, 92.24])”
specificityas written: “Specificity for pneumothorax”0.9051CI [88.18, 92.83]
source quote (p.7)
“Specificity 90.51% (95% CI: [88.18, 92.83])”
aurocas written: “AUC for pneumothorax”0.963CI [0.9521, 0.9739]
source quote (p.7)
“ROC AUC 0.9630 (95% CI: 0.9521 - 0.9739)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).