AVIEW CAC

K233211

Coreline Soft Co., Ltd. · cleared 2024-03-29 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The AVIEW CAC 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. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.”

Algorithmdeep learning for automatically segmenting the calcium area of the coronary artery

source quote (p.8)

“Automatically segments the calcium area of the coronary artery based on deep learning.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=150 cases

endpoints: agreement in coronary calcium scoring; concordance in coronary calcium scoring between the subject device and the predicate device

Reported performance (6 observations)

agreement_kappaas written: “ICC (Ground Truth, Total)”0.896CI 0.857,0.925

source quote (p.9)

“0.896(0.857,0.925)”

agreement_kappaas written: “ICC (Ground Truth, LCA)”0.927CI 0.899,0.947

source quote (p.9)

“0.927(0.899,0.947)”

agreement_kappaas written: “ICC (Ground Truth, RCA)”0.84CI 0.778,0.884

source quote (p.9)

“0.840(0.778,0.884)”

agreement_kappaas written: “ICC (Predicate, Total)”0.939CI 0.916,0.956

source quote (p.9)

“0.939(0.916,0.956)”

agreement_kappaas written: “ICC (Predicate, LCA)”0.955CI 0.938,0.968

source quote (p.9)

“0.955(0.938,0.968)”

agreement_kappaas written: “ICC (Predicate, RCA)”0.887CI 0.844,0.918

source quote (p.9)

“0.887(0.844,0.918)”

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) 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

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).