AVIEW RT ACS

K220408

Coreline Soft Co.,Ltd · cleared 2022-11-10 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.”
Algorithmdeep-learning-based auto-segmented organs
source quote (p.3)
“AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.”
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)

Retrospective clinical

n=120 cases

endpoints: Dice Similarity Coefficient (DSC); 95% Hausdorff Distance (HD)

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (DSC) for Brain”0.97CI 0.97, 0.98
source quote (p.10)
“0.97 ± 0.01(0.97, 0.98)”

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
0
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) 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

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/K220408