Lunit INSIGHT CXR Triage

K211733

Lunit Inc. · cleared 2021-11-10 · product code QFM · Radiology

FDA 510(k) summary for Lunit INSIGHT CXR Triage (K211733)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
2
Performance observations
6
Product code
QFM
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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).”
Algorithmartificial intelligence algorithm
source quote (p.3)
“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.”
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

Standalone

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)”
aurocas written: “ROC AUC (Pneumothorax)”0.963CI [0.9521, 0.9739]
source quote (p.7)
“ROC AUC 0.9630 (95% CI: 0.9521 - 0.9739)”
sensitivityas written: “Sensitivity (Pneumothorax)”0.8892CI [85.60, 92.24]
source quote (p.7)
“Sensitivity 88.92% (95% CI: 85.60 - 92.24)”
specificityas written: “Specificity (Pneumothorax)”0.9051CI [88.18, 92.83]
source quote (p.7)
“Specificity 90.51% (95% CI: 88.18 - 92.83)”

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
1
drift signals on this device
  • predicate_cohort_contagion

    K211733 shares predicate K183182 with K211161 (Critical Care Suite with Endotracheal Tube Positing AI algorithm), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K183182 sibling:K211161

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code QFM

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K211733