VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
K241439Vuno Inc. · cleared 2024-11-15 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a radiological computer-assisted triage and notification software”
Algorithmconvolutional neural network (CNN) which employs deep learning technology
source quote (p.6)
“analysis model, specifically a convolutional neural network (CNN), which employs deep learning technology to learn features from data.”
Adaptive (vs locked)No
source quote (p.6)
“A "locked" algorithm is used, and the same input gives the same results every time.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Retrospective clinical
n=716 scans
endpoints: triaging of pneumothorax
standards: ISO 14971:2019
Retrospective clinical
n=1,200 scans
endpoints: triaging of pleural effusion
standards: ISO 14971:2019
Reported performance (6 observations)
sensitivity0.9545CI 92.01 - 97.71
source quote (p.9)
“Sensitivity 95.45 % (95% CI: [92.01, 97.71])”
specificity0.9641CI 94.32 - 97.90
source quote (p.9)
“Specificity 96.41% (95% CI: [94.32, 97.90])”
aurocas written: “auc”0.9883CI 0.9815, 0.9939
source quote (p.9)
“AUC: 0.9883 (95% CI: [0.9815, 0.9939])”
sensitivityas written: “Sensitivity (Pleural Effusion)”0.9653CI 94.24 - 98.09
source quote (p.13)
“Sensitivity 96.53 (94.24 - 98.09)”
specificityas written: “Specificity (Pleural Effusion)”0.9511CI 93.37 - 96.50
source quote (p.13)
“Specificity 95.11 (93.37 - 96.50)”
aurocas written: “AUC (Pleural Effusion)”0.99CI 98.63 - 99.32
source quote (p.13)
“AUC 99.00 (95%CI, 98.63 - 99.32)”
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).