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)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Reader study (MRMC)

n=151 cases · 3 site(s)

endpoints: lung nodule detection performance; reading time

Standalone

n=282 cases · 3 site(s)

endpoints: sensitivity; specificity; ROC AUC; 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: “Overall sensitivity (with CI) 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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); 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/K221592