Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Optellum Ltd
Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyzes user-selected regions of interest (ROI) within lung CT data to provide volumetric and compute analysis based on morphological characteristics. Using only imaging features extracted from the CT image data, an artificial intelligence algorithm calculates a single value, the LCP-CNN score, which is displayed to the user. The LCPCNN score is analyzed relative to LCP-CNN scores generated on a database of cases with known ground-truth using a histogram display format. The LCP-CNN score may be useful in the characterization of pulmonary nodules during image interpretation and may be used as one input to clinical decision making when following published clinical guidelines. VNC’s LCP-CNN score is indicated for the evaluation of incidentally detected solid and semi-solid pulmonary nodules of diameter 5-30mm in patients aged 35 years or above. In cases where multiple abnormalities are present, VNC’s LCPCNN score can be used to assess each abnormality independently.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
- Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyzes user-selected regions of interest (ROI) within lung CT data to provide volumetric and compute analysis based on morphological characteristics. Using only imaging features extracted from the CT image data, an artificial intelligence algorithm calculates a single value, the LCP-CNN score, which is displayed to the user. The LCPCNN score is analyzed relative to LCP-CNN scores generated on a database of cases with known ground-truth using a histogram display format. The LCP-CNN score may be useful in the characterization of pulmonary nodules during image interpretation and may be used as one input to clinical decision making when following published clinical guidelines. VNC’s LCP-CNN score is indicated for the evaluation of incidentally detected solid and semi-solid pulmonary nodules of diameter 5-30mm in patients aged 35 years or above. In cases where multiple abnormalities are present, VNC’s LCPCNN score can be used to assess each abnormality independently.
Clinical-use display mirrors the best exact-submission purpose source because the reviewed FDA packet did not provide a more specific usable abstraction.
- Intended users
- Pulmonologists and radiologists (for CADx function); clinicians, nurses, nurse practitioners, and navigators (for management functions only, without access to LCP-CNN score)
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- CT/CTA images or data involving Heart/Cardiovascular; consult the FDA labeling for exact protocol, series, and quality requirements.
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The AI model outputs a single integer score (LCP-CNN score) between 1 and 10, where 1 indicates very likely benign and 10 indicates very likely malignant. The score is displayed alongside a histogram showing the distribution of scores from a database of malignant and benign nodules with known ground truth. The score is intended to aid characterization of incidentally detected solid and semi-solid pulmonary nodules and serve as one input to clinical decision making.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Scanner manufacturers: All
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Optellum Virtual Nodule Clinic, Optellum software, Optellum platform; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- Study type: Both. Reported accuracy: 86.70%. Reader-study cases: 300. Readers: 12
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- 5%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- 5%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K202300
- IndependenceIndependence not established
K202300
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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 exact K202300 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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
- The exact-identifier FDA recall query returned no native recall record for K202300. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify care setting and population: Confirm the intended care setting, patient population, and service line.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K202300 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Automated sources checkedStatus
2026-09-09Last searched
24Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, 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 K202300: Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform model card (K202300)
Scope: intendedUsers, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K202300
Scope: postmarketSafety
Research history
-
K202300 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
automated sources checked
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