Medical imaging and radiology
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Last updated: June 8, 2026
Back to directoryImbio Lung Density Analysis medical AI product profile
Regulatory-cleared CT lung analysis software from Imbio that segments lungs and quantifies low-attenuation areas associated with emphysema for clinician-reviewed reporting.
Medical imaging and radiology
Best fit
Programs that want quantitative lung-density analysis inside CT screening, COPD assessment, or pulmonology-radiology collaboration workflows with radiologist and pulmonologist review.
- Primary use case
- AI-assisted chest CT lung-density quantification, emphysema visualization, COPD component mapping, low-dose CT screening support, and patient LungMap reporting
- Audience
- Radiology groups, pulmonology programs, lung cancer screening teams, COPD clinics, CT imaging centers, and imaging AI governance committees
- Risk level
- High
- Pricing signal
- Commercial pricing is not public; verify current module, scanner/PACS workflow, implementation, reporting, region, and partner-distribution terms.
- Official sources
- 6 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Imbio Lung Density Analysis as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match deployment to the exact Imbio module, 510(k) K141069 or local authorization, CT protocol, intended user, report wording, and region; do not generalize lung-density clearance to autonomous diagnosis or unsupported lung-disease workflows. |
|---|---|
| Privacy | Review CT image routing, DICOM metadata, portal or partner delivery, uploaded-data responsibility, support access, retention, anonymization, international transfers, security controls, BAA or DPA terms, and patient-facing LungMap use. |
| Evidence | Evaluate Imbio's publication claims and FDA record against local low-dose CT, COPD, asthma, BOS, scanner, reconstruction, threshold, and reporting workflows, then track report edits and downstream clinical actions. |
| Workflow | Best governed as radiologist- and pulmonologist-reviewed quantitative CT support with documented thresholds, exception handling, patient counseling boundaries, smoking-cessation handoff, and post-deployment monitoring. |
Where Imbio Lung Density Analysis fits
Imbio describes Lung Density Analysis Inspiration as automated CT segmentation and quantification of low-attenuation lung areas for emphysema assessment, with FDA 510(k), CE Mark, and Health Canada claims; FDA records list Lung Density Analysis K141069 as an AI-enabled radiology device, and Imbio privacy/terms pages describe privacy, security, international transfer, and uploaded-data responsibility points that need enterprise review.
Not for: Standalone COPD diagnosis, replacing pulmonary function testing or physician interpretation, unsupported CT protocols, emergency triage, or treatment decisions without clinician confirmation.
What to verify before using Imbio Lung Density Analysis
- Which Imbio module is in scope: inspiration-only Lung Density Analysis, functional LDA, Lung Texture Analysis, CAC, airway analysis, partner-delivered workflow, or research use.
- FDA 510(k) K141069 status, CE/Health Canada claims, software version, CT acquisition requirements, threshold settings, intended users, and whether the deployment matches cleared labeling.
- How CT images, DICOM metadata, reports, LungMap patient materials, portal uploads, support access, retention, cross-border processing, BAA or DPA terms, and partner integrations are handled.
- Local validation for low-dose CT protocols, scanner mix, reconstruction kernels, emphysema thresholds, air-trapping interpretation, false reassurance, smoking-cessation workflow, and downstream care decisions.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.imbio.com / products / lung-density-analysis-inspiration
- www.imbio.com / products / lung-density-analysis-functional
- www.accessdata.fda.gov / scripts / cdrh
- www.fda.gov / medical-devices / software-medical-device-samd
- www.imbio.com / privacy-policy
- www.imbio.com / terms-and-conditions
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