AVIEW LCS

K193220

Coreline Soft Co., Ltd · cleared 2020-05-05 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“AVIEW LCS is intended for use as diagnostic patient imaging which is intended for the review and analysis of thoracic CT images. Provides following features as semi-automatic nodule measurement (segmentation), maximal plane measure, 3D measure and volumetric measures, automatic nodules detection by integration with 3rd party CAD. Also provides cancer risk based on PANCAN risk model which calculates the malignancy score based on numerical or Boolean inputs. Follow up support with automated nodule matching and automatically categorize Lung-RADS score which is a quality assurance tool designed to standardize lung cancer screening CT reporting and management recommendations that is based on type, size, size change and other findings that is reported. Better segmentation of lungs and lobes based on deep-learning algorithms.”
Algorithmdeep-learning algorithms
source quote (p.5)
“Better segmentation of lungs and lobes based on 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 (10)

Bench

sample size not stated

endpoints: establish the performance, functionality and reliability characteristics of the modified devices

Bench

n=28 other

endpoints: accuracy of Nodule-Matching using Lung Registration Result; applicability of Registry

Bench

n=28 other

endpoints: accuracy level of loss when using DVF subsampling; possibility of DVF size optimization

Bench

sample size not stated

endpoints: accuracy of the measured length and volume value in the node added by Segmentation

Bench

sample size not stated

endpoints: Confirm if CT DIOM is sent from AVIEW to MeVis CAD; Confirm that the CAD result SR DICOM is sent from the MeVis CAD to the AVIEW

Bench

sample size not stated

endpoints: accuracy of Brock Score calculation

Bench

sample size not stated

endpoints: VDT calculation accuracy

Bench

n=10 cases

endpoints: verify Lung-RADS calculation

Retrospective clinical

n=192 patients

endpoints: segmentation results classification by specialist and radiologist

Retrospective clinical

n=80 patients

endpoints: dice similarity coefficient

Reported performance (1 observation)

diceas written: “dice similarity coefficient”stated without value
source quote (p.12)
“The dice similarity coefficient is performed to check how similar they are.”

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
29
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K200714 (decision 2020-08-26) 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:K200714

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • …and 23 more.

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K193220