AVIEW Lung Nodule CAD

K221592

Coreline Soft Co.,Ltd. · cleared 2023-02-24 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review of CT examinations of the chest for asymptomatic populations.”

AlgorithmDeep Convolution Neural Network (CNN) based algorithm

source quote (p.5)

“The lung nodule detection model was trained by Deep Convolution Neural Network (CNN) based algorithm from the chest CT image.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Reader study (MRMC)

n=282 cases · 3 site(s)

endpoints: lung nodule detection performance; reading time; sensitivity; specificity; ROC; FROC

Reported performance (5 observations)

sensitivity0.907CI (0.846-0.95)

source quote (p.12)

“Overall Sensitivity (with CI): 0.907(0.846-0.95)”

specificity0.704CI (0.622-0.778)

source quote (p.12)

“Overall Specificity (with CI): 0.704(0.622-0.778)”

aurocas written: “auc”0.961CI (0.939-0.983)

source quote (p.12)

“Overall AUC (with CI): 0.961(0.939-0.983)”

false_positive_rate_per_imageas written: “FP/scan”0.28CI (0.15-0.42)

source quote (p.11)

“0.28 (0.15-0.42)”

false_positive_rate_per_imageas written: “Sensitivity at FP/scan<2”0.889CI (0.849-0.93)

source quote (p.12)

“Overall sensitivity (with CI) at FP/scan<2: 0.889(0.849-0.93) at FP/scan=0.504”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K251203 (decision 2025-12-03) from Coreline Soft Co.,Ltd for a matching device line ("AVIEW Lung Nodule CAD") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251203
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243689 (decision 2025-03-19) from Coreline Soft Co., Ltd. for a matching device line ("AVIEW") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243689

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).