FDA-cleared profile
Coreline Soft Co., Ltd.
AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets. The FDA indication describes lung, lobe, airway, fissure, nodule, and cardiac analysis, including nodule measurements, Lung-RADS support, and coronary calcium scoring, for adult patients.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Prior source-backed dossier value: Supported medical images, DICOM metadata, patient and protocol information, and release-specific user inputs.
Prior source-backed dossier value: Images, segmentations, measurements, models, calculations, overlays, or reports that require professional review.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The exact FDA material describes this input or interface boundary; local interoperability acceptance remains necessary. This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
The exact FDA material describes this release-level deployment boundary; hosting, contracts, security, availability, and site configuration remain separate evidence. This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K243689 before acceptance. Later family features are not evidence for this exact submission.
exact submission · checked 2026-09-04The FDA indication describes CT data storage, transfer, inquiry, and display in on-premises or cloud environments; validate the exact DICOM, identity, routing, archive, and deployment contract locally. Test representative identifiers, geometry, measurements, units, routing, failure handling, and round trips locally.
exact submission · checked 2026-09-04The FDA indication describes on-premises and cloud environments; hosting region, availability, security, retention, and contract responsibilities are not established by that indication. Security, availability, retention, and service responsibilities remain unverified.
exact submission · checked 2026-09-04Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The FDA indication is limited to adult patients. Quantitative values, segmentation, nodule characterization, Lung-RADS support, and calcium-risk information require qualified-physician review and the exact supported CT inputs.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs. No exact-product price was found.
product family · checked 2026-09-04Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The FDA indication is limited to adult patients. Quantitative values, segmentation, nodule characterization, Lung-RADS support, and calcium-risk information require qualified-physician review and the exact supported CT inputs.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
The FDA material describes on-premises, cloud, mobile, and Chrome access paths; current hosting, service, security, retention, and enabled-module configuration remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified. Sensitivity is not promoted as a product-wide endpoint.
Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified. Specificity is not promoted as a product-wide endpoint.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) substantial-equivalence review of the exact submission, device description, indications, and verification or validation documentation. · Chest/lung and heart/coronary arteries
exact submission · Tested version: AVIEW · Sponsor or vendor studyK243689
The FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared or approved configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs. No public list price for the exact cleared configuration was found.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals. Prior source-backed dossier value: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K243689 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed and four ClinicalTrials.gov records. AVIEW publications use different or unstated AVIEW versions and functions, and all four trials concern the unrelated Ambu aView display; no record links the tested release to K243689. All 24 were quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 4 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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