AVIEW

K214036

Coreline Soft Co.,Ltd. · cleared 2022-12-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The AVIEW is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving, and sending images by using software tools. And is intended for use as a quantitative analysis of CT scanning. [...] Fully automatic lungs, lobes and airways segmentation using deep-learning algorithms [...] Automatically segments calcium area of coronary artery based on deep learning.”

Algorithmdeep-learning algorithms

source quote (p.9)

“Fully automatic lungs, lobes and airways segmentation using deep-learning algorithms”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=96 other

Reader study (MRMC)

n=129 patients

endpoints: Kappa; ICC

Reported performance (2 observations)

agreement_kappaas written: “Kappa”stated without value

source quote (p.13)

“Kappa and ICC were also reported.”

agreement_kappaas written: “ICC”stated without value

source quote (p.13)

“Kappa and ICC were also reported.”

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
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

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).