AVIEW

K200714

Coreline Soft Co., Ltd · cleared 2020-08-26 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The AVIEW is a software product which can be installed on a PC. Fully automatic lung/lobe segmentation using deep-learning algorithms.”
Algorithmdeep learning algorithms
source quote (p.6)
“Fully automatic lung/lobe segmentation using deep-learning algorithms. Fully automatic airway segmentation using deep-learning algorithms. Better segmentation of lungs, lobes and airway based on deep-learning algorithms. Automatically segments calcium area of coronary artery based on deep learning”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Functional test condition for software component unit, Performance test condition, and part of algorithm analysis for image processing algorithm.; Auto Lung & Lobe Segmentation; Airway Segmentation; Nodule Matching Experiment Using Lung Registration; Validation on DVF Size Optimization with Sub-sampling; Semi-automatic Nodule Segmentation

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
33
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K214036 (decision 2022-12-23) 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:K214036

  • …and 27 more.

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/K200714