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.”
AlgorithmThe device uses deep-learning algorithms for fully automatic segmentation of lungs, lobes, and airways, and for automatically segmenting calcium areas of coronary arteries. It also performs automatic nodule detection and uses the Brocks model to calculate malignancy scores.
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)

Retrospective clinical

n=96 cases

endpoints: LAA result reliability

Retrospective clinical

n=129 patients

endpoints: Bland Altman plots; 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
5
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); 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/K214036