AVIEW Lung Nodule CAD

K251203

Coreline Soft Co.,Ltd · cleared 2025-12-03 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The AVIEW Lung Nodule CAD is a software product that detects nodules in the lung.”
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 addressedYes
source quote (p.6)
“In accordance with the guidance of 'Cybersecurity in Medical Devices: Quality System Considerations and Pre-marketing Submissions', we conducted the following tests to comply with cybersecurity requirements. - Penetration Test”

Validation studies (1)

Bench

sample size not stated

endpoints: Penetration Test; Unit Test; System Test; Regression Test

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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/K251203