VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

K241439

Vuno Inc. · cleared 2024-11-15 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an automated computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pleural effusion and pneumothorax. It is based on an artificial intelligence”
Algorithmconvolutional neural network (CNN) which employs deep learning technology
source quote (p.6)
“It is based on an artificial intelligence 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: classification accuracy; timing of notification

standards: ISO 14971:2019

Retrospective clinical

n=1,200 scans

endpoints: classification accuracy; timing of notification

standards: ISO 14971:2019

Reported performance (3 observations)

sensitivity95.45CI 92.01 - 97.71
source quote (p.12)
“The AUC of the subject device in triaging scans with findings suspicious of pneumothorax exceeded the acceptance criteria with AUC 98.83 (95%CI, 98.15 - 99.39), Sensitivity 95.45 (92.01 - 97.71), and Specificity 96.41 (94.32 - 97.90).”
specificity96.41CI 94.32 - 97.90
source quote (p.12)
“The AUC of the subject device in triaging scans with findings suspicious of pneumothorax exceeded the acceptance criteria with AUC 98.83 (95%CI, 98.15 - 99.39), Sensitivity 95.45 (92.01 - 97.71), and Specificity 96.41 (94.32 - 97.90).”
aurocas written: “auc”0.9883CI 98.15 - 99.39
source quote (p.12)
“The AUC of the subject device in triaging scans with findings suspicious of pneumothorax exceeded the acceptance criteria with AUC 98.83 (95%CI, 98.15 - 99.39), Sensitivity 95.45 (92.01 - 97.71), and Specificity 96.41 (94.32 - 97.90).”

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); 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241439