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.”
Algorithmdeep learning
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)

Bench

n=300 cases

endpoints: agreement in coronary calcium scoring (ICC)

Reported performance (6 observations)

agreement_kappaas written: “ICC (Ground Truth - Total)”0.896CI 0.857,0.925
source quote (p.9)
“ICC (95% CI) 0.896(0.857,0.925)”
agreement_kappaas written: “ICC (Ground Truth - LCA)”0.927CI 0.899,0.947
source quote (p.9)
“ICC (95% CI) 0.927(0.899,0.947)”
agreement_kappaas written: “ICC (Ground Truth - RCA)”0.84CI 0.778,0.884
source quote (p.9)
“ICC (95% CI) 0.840(0.778,0.884)”
agreement_kappaas written: “ICC (Predicate - Total)”0.939CI 0.916,0.956
source quote (p.9)
“ICC (95% CI) 0.939(0.916,0.956)”
agreement_kappaas written: “ICC (Predicate - LCA)”0.955CI 0.938,0.968
source quote (p.9)
“ICC (95% CI) 0.955(0.938,0.968)”
agreement_kappaas written: “ICC (Predicate - RCA)”0.887CI 0.844,0.918
source quote (p.9)
“ICC (95% CI) 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
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); 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/K233211