Radiology AI Directory

FDA-cleared profile

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.

Lung nodule detectionDetection and CADeQuantification and segmentationChest CT
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
Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult chest CT review; asymptomatic patients aged at least 55 years.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Adjunctive detection, localization, measurement and longitudinal comparison
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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.

FDA submission
K240554
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Controlled CT/CTA category; this does not add a separate CTA indication.

Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-05-16
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Hybrid
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

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.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

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.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

User reporting instructions are not evidence of automated clinical drift monitoring.

DICOM and longitudinal review

CT DICOM input with prior/current nodule matching and manual registration adjustment.

exact submission · checked 2026-09-05
Source

Family safety workflow

Global V2 labeling calls for user training, patient-label verification and incident reporting.

product family · checked 2026-09-05
Source

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
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

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
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

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

Source

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

Source

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

Source

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Reviewed labeling and FDA materials do not establish license, hosting, interface or service costs.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

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
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

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

Open evaluation checklist

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

  1. InferRead Lung CT.AI: K240554 clearance and summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, deployment, integration, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. InferRead Lung CT.AI model card (K240554)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. InferRead CT Lung V2 intended use and warnings

    Infervision - Accessed 2026-09-05

    Scope: productFamilyContext, training, monitoring, implementationCapabilities

Research history

  1. K240554 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
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