DICOM and longitudinal review
CT DICOM input with prior/current nodule matching and manual registration adjustment.
exact submission · checked 2026-09-05FDA-cleared profile
InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Authorized purpose: Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
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 pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest/Lung Input: Chest CT in DICOM format with both lungs in the field of view; original CT series must be available. Prior and current examinations support temporal comparison.
- Who uses it? Intended users: Radiologists
- What does the software produce? Output: CADe overlays and nodule segmentation, longest/shortest and mean diameters, volume, mean HU density, lobar location and prior/current nodule matching with increased, decreased, new, disappeared or unchanged status.
- What is its most important limitation? Key limitation: Adjunctive information only; not for use without the original CT series. Both lungs must be in view and the labeled age, asymptomatic population and nodule-size restrictions apply.
Clinical takeaway
Clinical role: Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
Evidence takeaway
Evidence from the reviewed source record: K240554 reports separate standalone cohorts for longitudinal nodule matching (98 cases), lobar location (94 scans) and lung/lobe segmentation (22 cases). Nodule detection/segmentation consistency with the predicate was assessed separately.
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 pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
- Intended users
- Radiologists
- Care setting and population
- Adult chest CT review; asymptomatic patients aged at least 55 years.
- Workflow role
- Adjunctive detection, localization, measurement and longitudinal comparison
- Required input
- Chest CT in DICOM format with both lungs in the field of view; original CT series must be available. Prior and current examinations support temporal comparison.
- Output and human action
- CADe overlays and nodule segmentation, longest/shortest and mean diameters, volume, mean HU density, lobar location and prior/current nodule matching with increased, decreased, new, disappeared or unchanged status.
- Limitations
- Adjunctive information only; not for use without the original CT series. Both lungs must be in view and the labeled age, asymptomatic population and nodule-size restrictions apply.
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
- DICOM CT processing with temporal registration/nodule matching and manual adjustment of registration results.
- Deployment and data flow
- Hybrid
Baseline category retained. The summary describes facility-based or cloud deployment alternatives, not a requirement that both run simultaneously.
- Security and privacy
- Vendor documentation pending
Exact-release hosting geography, access controls, retention and scoped security assurance remain unverified.
- Training and support
- The vendor's global V2 labeling describes hospital-administrator training and necessary operator/user training before use.
Global V2 labeling is not linked to the exact US K240554 build or a priced training contract.
- Monitoring and change control
- Global V2 warnings ask users to report missed/misdiagnoses and serious incidents and to verify patient labels when identifying information is absent.
User reporting instructions are not evidence of automated clinical drift monitoring.
Family safety workflow
Global V2 labeling calls for user training, patient-label verification and incident reporting.
product family · checked 2026-09-05Evidence
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
- K240554 reports separate standalone cohorts for longitudinal nodule matching (98 cases), lobar location (94 scans) and lung/lobe segmentation (22 cases). Nodule detection/segmentation consistency with the predicate was assessed separately.
Refines baseline ACR 214 cases: 98+94+22 is a sum of test cohorts, not a verified unique-patient total or a new reader diagnostic-sensitivity cohort.
- Reported sensitivity
- Not established in reviewed sources
Matching, lobar localization and Dice segmentation results are not diagnostic nodule-detection sensitivity; no exact-release estimate promoted.
- Reported specificity
- Not established in reviewed sources
No exact-release specificity estimate established from the reviewed new-feature tests.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K240554 longitudinal nodule matching validation
- DesignStandalone comparison of automatic matching against reference nodule pairs
- Population98 screening cases with 206 nodule pairs
- Scopeexact submission
- Tested versionInferRead Lung CT.AI K240554
- Samplen=98
- IndependenceSponsor or vendor study
K240554
K240554 lobar localization validation
- DesignStandalone nodule lobar-location evaluation
- Population94 CT scans containing 188 nodules
- Scopeexact submission
- Tested versionInferRead Lung CT.AI K240554
- Samplen=94
- IndependenceSponsor or vendor study
K240554
K240554 lung/lobe segmentation validation
- DesignStandalone segmentation overlap comparison
- Population22 cases with 110 lung lobes
- Scopeexact submission
- Tested versionInferRead Lung CT.AI K240554
- Samplen=22
- IndependenceSponsor or vendor study
K240554
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
Reviewed labeling and FDA materials do not establish license, hosting, interface or service costs.
- Reimbursement and coding
- Research pending
No applicable payer policy reviewed; screening eligibility in labeling does not itself establish payer eligibility or separate software payment.
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
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: Exact-release hosting geography, access controls, retention and scoped security assurance remain unverified.
- Verify pricing and total cost: Reviewed labeling and FDA materials do not establish license, hosting, interface or service costs.
- Verify reimbursement and coding relevance: No applicable payer policy reviewed; screening eligibility in labeling does not itself establish payer eligibility or separate software payment.
- Verify recalls and postmarket safety signals: 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.
Human reviewedStatus
2026-09-05Last searched
21Fields reviewed
10Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads
Stored metadata for Clinical Validation of InferRead Lung CT.AI screened. Live registry page returned only a shell and no readable study details. No exact K240554 linkage or trial results promoted; full record review remains unresolved. The current discovery snapshot contains 0 PubMed and 1 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 instructions for use, 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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InferRead Lung CT.AI: K240554 clearance and summary
Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, deployment, integration, evidenceStudies
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
InferRead Lung CT.AI model card (K240554)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
InferRead CT Lung V2 intended use and warnings
Scope: productFamilyContext, training, monitoring, implementationCapabilities
Research history
-
K240554 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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