Radiology AI Directory

FDA-cleared profile

Lung-CAD

Imagen Technologies, Inc

Lung-CAD is a concurrent-read computer-aided detection aid for identifying and marking regions of interstitial thickening on adult chest radiographs; it does not provide a clinical diagnosis or replace physician review or other tests.

Detection and CADe
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Lung-CAD is a concurrent-read computer-aided detection aid for identifying and marking regions of interstitial thickening on adult chest radiographs; it does not provide a clinical diagnosis or replace physician review or other tests.
FDA source Exact FDA submission Checked 2026-09-04
Intended users
Physicians and other qualified healthcare professionals interpreting adult chest radiographs.
FDA source Exact FDA submission Checked 2026-09-04
Care setting and population
Hospital and radiology chest-radiography workflows.
FDA source Exact FDA submission Checked 2026-09-04
Workflow role
Analyzes a chest radiograph and returns DICOM presentation-state overlays or a no-ROI message for concurrent physician review.
FDA source Exact FDA submission Checked 2026-09-04
Required input
Adult chest radiographs received through the supported DICOM radiography workflow.
FDA source Exact FDA submission Checked 2026-09-04
Output and human action
DICOM Presentation State with deep-learning regions of interest labeled interstitial thickening, or the text message No Lung-CAD ROI(s) when no region is marked.
FDA source Exact FDA submission Checked 2026-09-04
Limitations
Adults and interstitial thickening on chest radiographs only; the software is a concurrent aid, not a diagnosis or replacement for physician review, other tests, or clinical judgment, and false positives or negatives remain possible.
FDA source Exact FDA submission Checked 2026-09-04

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
K223811
FDA source Exact FDA submission Checked 2026-08-31
Modality
X-ray/Radiography
FDA source Exact FDA submission Checked 2026-09-04
Anatomy
Chest/Lung
FDA source Exact FDA submission Checked 2026-09-04
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2023-09-13
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
The FDA material describes DICOM input and DICOM Presentation State output with per-image regions of interest or a no-ROI message.
FDA source Exact FDA submission Checked 2026-09-04

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.

Deployment and data flow
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

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.

Training and support
Only Physicians and other qualified healthcare professionals interpreting adult chest radiographs should operate or interpret the product; local onboarding must cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
FDA source Exact FDA submission Checked 2026-09-04
Monitoring and change control
Monitor K223811 by exact hardware, software, model, algorithm 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: Adults and interstitial thickening on chest radiographs only; the software is a concurrent aid, not a diagnosis or replacement for physician review, other tests, or clinical judgment, and false positives or negatives remain possible.
FDA source Exact FDA submission Checked 2026-09-04

Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K223811 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA material describes DICOM input and DICOM Presentation State output with per-image regions of interest or a no-ROI message.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use 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. Adults and interstitial thickening on chest radiographs only; the software is a concurrent aid, not a diagnosis or replacement for physician review, other tests, or clinical judgment, and false positives or negatives remain possible.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

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.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K223811 by exact hardware, software, model, algorithm 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.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K223811 FDA material reports standalone testing on 5,000 chest radiograph cases with sensitivity 0.913, specificity 0.866, and ROC AUC 0.961 for the labeled interstitial-thickening endpoint; these values are exact-study metrics, not a general clinical outcome claim.
FDA source Exact FDA submission Checked 2026-09-04
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
95%
FDA source Exact FDA submission Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Interstitial-thickening sensitivity

0.913 proportion

Standalone case-level sensitivity in 5,000 chest radiograph cases.

Tested version: Lung-CAD configuration described in K223811
Source

Interstitial-thickening specificity

0.866 proportion

Standalone case-level specificity in 5,000 chest radiograph cases.

Tested version: Lung-CAD configuration described in K223811
Source

Interstitial-thickening ROC AUC

0.961 ROC AUC

Standalone discrimination in 5,000 chest radiograph cases.

Tested version: Lung-CAD configuration described in K223811
Source

K223811 FDA evidence package for Lung-CAD

FDA 510(k) standalone performance evaluation of the exact deep-learning chest-radiograph detector. · 5,000 adult chest radiograph cases with positive and negative interstitial-thickening reference labels.

exact submission · Tested version: Lung-CAD configuration described in K223811 · n=5000 · Sponsor or vendor study

K223811

The FDA summary reports a 2.5% positive-case prevalence in the test cohort; the endpoint is detection of interstitial thickening, not diagnosis or patient outcome.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
Public source Not applicable Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K223811 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

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
2026-09-04Last searched
32Fields reviewed
11Source classes checked
14Reviewed PubMed leads
1Reviewed trial leads
0Unreviewed FDA recall leads

Screened 14 PubMed and one ClinicalTrials.gov record. They concern M5L or other lung CAD and CT systems rather than Imagen Technologies Lung-CAD or K223811; all 15 were quarantined and none was promoted. The current discovery snapshot contains 14 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

Alternatives

Related tools to compare

FDA-cleared K232410

SmartChest

Milvue

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2024-05-10
Detection and CADeAcute triage and notification