Nodule detection and quantification
The cleared output marks detected nodules and provides ROI and quantified nodule values for radiologist review.
exact submission · checked 2026-09-07FDA-cleared profile
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd
Authorized purpose: Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest/Lung Input: Non-contrast chest CT for asymptomatic populations; FDA recommends limiting use to Siemens SOMATOM series because the validation data were predominantly from that scanner family.
- Who uses it? Intended users: Radiologists and other qualified healthcare professionals interpreting chest CT.
- What does the software produce? Output: Detected pulmonary nodules with marked regions of interest and quantified nodule values for radiologist review.
- What is its most important limitation? Key limitation: The software is an adjunct, not a replacement for radiologist interpretation. The cleared population is asymptomatic, the input is non-contrast chest CT, and the FDA summary recommends limiting use to Siemens SOMATOM series.
Clinical takeaway
Clinical role: Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
Evidence takeaway
Evidence from the reviewed source record: The FDA summary describes nonclinical/software validation for nodule detection and analysis and states that no clinical study was considered necessary for this submission.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
- Intended users
- Radiologists and other qualified healthcare professionals interpreting chest CT.
- Care setting and population
- Healthcare imaging services using non-contrast chest CT.
- Workflow role
- Adjunctive alert and second reader after the radiologist's first read.
- Required input
- Non-contrast chest CT for asymptomatic populations; FDA recommends limiting use to Siemens SOMATOM series because the validation data were predominantly from that scanner family.
- Output and human action
- Detected pulmonary nodules with marked regions of interest and quantified nodule values for radiologist review.
- Limitations
- The software is an adjunct, not a replacement for radiologist interpretation. The cleared population is asymptomatic, the input is non-contrast chest CT, and the FDA summary recommends limiting use to Siemens SOMATOM series.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Processes the CT study and presents nodule findings as radiologist-review information in the imaging workflow; exact local routing and PACS configuration require site confirmation.
- Deployment and data flow
- Standalone software configuration described in the submission; the exact hosting and local service topology are not specified in the public summary.
- Security and privacy
- Vendor documentation pending
The FDA packet notes cybersecurity testing, but exact-release security controls, retention and contractual assurances were not established.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Family chest CT workflow
Coreline presents AVIEW LCS as a chest CT nodule detection and analysis solution with report-oriented output.
product family · checked 2026-09-06The family page does not establish local PACS routing, hosting, service levels or current availability for K251203.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The FDA summary describes nonclinical/software validation for nodule detection and analysis and states that no clinical study was considered necessary for this submission.
- Reported sensitivity
- Not established in reviewed sources
No single exact-submission clinical sensitivity endpoint was established in the reviewed FDA summary.
- Reported specificity
- Not established in reviewed sources
No single exact-submission clinical specificity endpoint was established in the reviewed FDA summary.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
AVIEW Lung Nodule CAD K251203 validation
- DesignNonclinical and software validation described in the FDA 510(k) summary
- PopulationNon-contrast chest CT studies with pulmonary nodules in the cleared 3-20 mm range, predominantly acquired on Siemens SOMATOM scanners
- Scopeexact submission
- Tested versionAVIEW Lung Nodule CAD 2.0
- IndependenceSponsor or vendor study
K251203
The public summary does not establish a clinical-outcome study or one consolidated sensitivity/specificity result.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the K251203 configuration was reviewed.
- Reimbursement and coding
- Research pending
Payer policy research was not part of this worker's scope.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- Not established in reviewed sources
The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: The FDA packet notes cybersecurity testing, but exact-release security controls, retention and contractual assurances were not established.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: No public price or quote for the K251203 configuration was reviewed.
- Verify reimbursement and coding relevance: Payer policy research was not part of this worker's scope.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
19Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. The current discovery snapshot contains 0 PubMed and 0 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, vendor product page, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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FDA 510(k) K251203: AVIEW Lung Nodule CAD
Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, evidenceStudies
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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AVIEW Lung Nodule CAD model card (K251203)
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
AVIEW LCS | AI for Nodule Detection & Analysis
Scope: productFamilyContext, clinicalUse, output, implementationCapabilities
Research history
-
K251203 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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