AVIEW

K200714

Coreline Soft Co., Ltd · cleared 2020-08-26 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“The AVIEW is a software product which can be installed on a PC.”

Algorithmdeep-learning algorithms for lung/lobe segmentation, airway segmentation, and coronary artery calcium area segmentation

source quote (p.6)

“Fully automatic lung/lobe segmentation using deep-learning algorithms. Fully automatic airway segmentation using deep-learning algorithms. Automatically segments calcium area of coronary artery based on deep learning”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: performance, functionality and reliability characteristics of the modified devices; Functional test condition for software component unit, Performance test condition, and part of algorithm analysis for image processing algorithm; Success standard of System Test is not finding 'Major', 'Moderate' defect

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243696 (decision 2025-02-14) from Coreline Soft Co., Ltd. for a matching device line ("AVIEW CAC") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243696
re_clearance
The FDA AI/ML device list shows a newer 510(k) K233211 (decision 2024-03-29) from Coreline Soft Co., Ltd. for a matching device line ("AVIEW CAC") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233211
re_clearance
The FDA AI/ML device list shows a newer 510(k) K221592 (decision 2023-02-24) 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:K221592
re_clearance
The FDA AI/ML device list shows a newer 510(k) K214036 (decision 2022-12-23) 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:K214036
…and 27 more.

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).