AVIEW CAC

K243696

Coreline Soft Co., Ltd. · cleared 2025-02-14 · 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.”

AlgorithmAutomatically analyzes coronary arteries from segmented arteries to calculate calcium score and arterial age based on Agatston score.

source quote (p.5)

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

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

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

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

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).