Last updated: May 25, 2026
Back to directoryAI for radiology, cardiology imaging, pathology imaging, triage, detection, reporting, and care coordination around images.
| Regulatory / FDA | Match FDA, CE, UKCA, or local authorization to the exact modality, anatomy, disease state, and intended use. |
|---|---|
| Privacy | Verify image routing, cloud processing, retention, access controls, DICOM metadata handling, and vendor security review. |
| Evidence | Review validation data for the deployment population, scanner types, prevalence, false positives, false negatives, and outcome evidence. |
| Workflow | Define PACS/RIS/EHR integration, alert routing, radiologist review, escalation rules, and post-deployment monitoring. |
| Product | Best fit | First verification check | Official sources |
|---|---|---|---|
| Aidoc | Health systems deploying multiple imaging AI algorithms and governance workflows. | FDA-cleared algorithms that match your exact modality and use case. | 4 official sources |
| Viz.ai | Teams that need rapid disease detection alerts and coordinated response pathways. | Which algorithms are FDA-cleared for your use case. | 4 official sources |
| Ferrum Health | Organizations that need one governed integration layer for FDA-cleared, CE-marked, open-source, homegrown, or vendor AI models rather than one-off radiology deployments. | Which models, service lines, PACS/RIS/EHR connections, deployment fabric, and governance modules are included in the scope. | 4 official sources |
| Blackford Platform | Health systems that want one governed infrastructure layer for radiology AI rather than point integrations for every algorithm. | Which Blackford Platform functions and marketplace applications are in scope. | 4 official sources |
| Brainomix 360 Stroke | Hospitals and regional stroke networks that need AI-assisted imaging triage, ASPECTS support, LVO/collateral assessment, and transfer coordination under specialist review. | Which Brainomix 360 Stroke modules are in scope, such as e-ASPECTS, e-CTA, Triage Stroke, core-volume, e-MRI, or mobile notifications. | 5 official sources |
| Qure.ai | Organizations evaluating imaging AI for public health, lung cancer, TB, and emergency workflows. | Product-specific clearance and local regulatory status. | 4 official sources |
| Rad AI | Radiology groups that want report drafting support while keeping radiologists in the final-sign workflow. | Whether the product handles your modalities and templates. | 3 official sources |
| Cleerly | Cardiology and imaging teams using CCTA to quantify and track coronary plaque. | Regulatory status and intended use in your country. | 5 official sources |
| Elucid PlaqueIQ | Cardiology and imaging teams evaluating quantitative CCTA plaque analysis for atherosclerosis risk assessment and treatment planning. | FDA 510(k) indication, software version, and whether the intended coronary CTA workflow matches the clearance. | 5 official sources |
| LumineticsCore | Primary-care or diabetes-care settings that need point-of-care diabetic eye exam workflows with defined referral instructions. | FDA De Novo authorization, indications for use, contraindications, and exact eligible patient population. | 4 official sources |
| Eyenuk EyeArt | Diabetes and primary-care workflows that need in-clinic diabetic eye screening with supported cameras, trained operators, referral rules, and clinician oversight. | FDA 510(k) record, current EyeArt version, supported camera models, intended-use language, and eligible patient population. | 5 official sources |
| RapidAI | Hospitals evaluating stroke, vascular, aortic, hemorrhage, or other imaging workflows that need integrated alerts and care coordination. | Which RapidAI module is in scope and whether its clearance matches the exact modality, anatomy, and intended use. | 6 official sources |
| Heartflow | Cardiology and imaging programs using CCTA to evaluate coronary artery disease and support treatment planning. | Which Heartflow product is being used: FFRCT, Plaque Analysis, Roadmap Analysis, or another module. | 6 official sources |
| Ultromics EchoGo | Heart-failure and echo programs evaluating structured AI support for HFpEF workups in clinician-reviewed workflows. | Whether the selected EchoGo Heart Failure version and 510(k) clearance match the intended echocardiography workflow. | 4 official sources |
| Gleamer BoneView | Teams that need fracture-detection support for high-volume trauma X-rays while preserving radiologist or clinician interpretation. | FDA K222176 intended use, covered anatomy, patient age limits, warnings, and region-specific availability. | 4 official sources |
| iCAD ProFound AI | Breast imaging programs comparing AI assistance for 2D mammography, digital breast tomosynthesis, case prioritization, and mammography workflow support. | Which module is in scope: ProFound Detection, ProFound AI for DBT, density assessment, risk scoring, or another breast-health workflow. | 4 official sources |
| ScreenPoint Transpara | Breast screening programs comparing AI second-reader, case-scoring, density, and prior-comparison workflows for radiologist-reviewed mammography. | Which Transpara module is in scope: Detection, Density, Temporal Comparison, or another breast AI workflow. | 3 official sources |
| Koios DS Breast | Breast ultrasound teams evaluating adjunctive CADx support while preserving trained physician interpretation and BI-RADS workflow responsibility. | Whether Koios DS Breast, Koios DS, or another module/version matches the intended breast ultrasound workflow. | 4 official sources |
| Subtle Medical | Imaging teams evaluating AI image-enhancement and scan-time workflows rather than diagnostic detection or triage algorithms. | Which tool is in scope: SubtleMR, SubtlePET, SubtleHD, SubtleSYNTH, SubtleALIGN, or an integrated partner workflow. | 6 official sources |
| Lunit | Organizations evaluating cancer-screening AI, mammography or chest X-ray support, and oncology research workflows that need product-specific regulatory review. | Which module is in scope: INSIGHT MMG, INSIGHT DBT, INSIGHT CXR, SCOPE IO, SCOPE IHC, SCOPE GP, or a Volpara-derived workflow. | 3 official sources |
| annalise.ai | Radiology teams that need broad CXR or head CT finding coverage with region-specific regulatory and workflow review. | Which product is being evaluated: Annalise Enterprise CXR, Enterprise CTB, Annalise Triage, Reporting, or a regional Harrison.ai-branded workflow. | 4 official sources |
| CureMetrix | Breast imaging programs evaluating suspicious-case prioritization for 2D screening mammography while keeping radiologists responsible for interpretation. | Whether the exact CureMetrix module is cmTriage, cmAssist, or another breast-imaging workflow. | 3 official sources |
| GE HealthCare Caption AI | Organizations expanding point-of-care cardiac ultrasound access while keeping image acquisition, interpretation, and escalation under trained clinical oversight. | Which GE ultrasound system, Caption Guidance feature, or Caption Interpretation AutoEF workflow is in scope. | 4 official sources |
| Butterfly iQ3 | Programs that need scalable POCUS workflows with training, credentialing, exam management, and AI-assisted acquisition or measurement under clinical governance. | Which probe generation, software plan, AI feature, and clinical workflow is being deployed. | 4 official sources |
| Pearl Second Opinion | Dental teams evaluating chairside second-reader support and patient-facing visuals for radiographic findings. | Which Pearl module is in scope: Second Opinion 2D, Second Opinion 3D, bone-level features, claims review, or another workflow. | 5 official sources |
| Overjet | Dental organizations comparing AI for caries detection, periodontal bone-level measurement, radiograph enhancement, and standardized clinical communication. | Which product is being used: Vision AI, Dental Assist, Caries Assist, IRIS, image enhancement, payer review, voice, or insurance verification. | 6 official sources |
| VideaAI | Dental organizations that want radiographic AI, patient-facing visuals, and rollout support across multiple locations. | Which Videa product is in scope: Clinical Assist, Patient View, Daily Dashboard, Voice Notes, Clean Claims, AutoVerify, or another platform module. | 4 official sources |
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Clinical AI platform for radiology and enterprise imaging workflows.
AI-powered care coordination platform with imaging-driven alerts across therapeutic areas.
Clinical AI governance and deployment platform for health systems adopting multiple imaging or clinical AI models.
Enterprise medical imaging AI platform for evaluating, deploying, routing, and monitoring multiple radiology AI applications.
Stroke imaging AI platform that supports real-time interpretation of brain scans and stroke-network coordination.
Medical imaging AI platform used for disease detection and care pathways.
Generative AI software for radiology reporting and workflow efficiency.
AI-enabled CCTA analysis platform for coronary plaque assessment and heart attack prevention workflows.
FDA-cleared non-invasive plaque analysis software for coronary CTA workflows that reports plaque composition and vessel-level findings.
FDA De Novo-cleared autonomous diagnostic AI for detecting more-than-mild diabetic retinopathy in eligible adults with diabetes.
FDA-cleared autonomous diabetic retinopathy screening system that analyzes retinal images and returns patient-level and eye-level screening results.
Enterprise imaging AI platform for acute and longitudinal clinical workflows, including FDA-cleared imaging modules.
Non-invasive AI heart-care platform for coronary CTA-derived anatomy, physiology, and plaque information.
FDA-cleared echocardiography AI that analyzes apical four-chamber clips to support detection of heart failure with preserved ejection fraction.
Radiology AI product for detecting and highlighting fractures on trauma X-rays inside clinician-reviewed reading workflows.
Breast health AI suite for mammography detection, scoring, density assessment, and risk-related workflows.
Breast AI suite for 2D mammography and digital breast tomosynthesis workflows, including detection and density support.
Smart ultrasound software that analyzes breast ultrasound images and supports physician risk assessment for suspicious lesions.
AI imaging software company focused on improving MRI and PET image quality and acquisition workflows.
Cancer-focused medical AI company with imaging and precision-oncology products spanning Lunit INSIGHT and Lunit SCOPE workflows.
Radiology AI company offering Annalise Enterprise and Annalise Triage products for CXR and non-contrast head CT workflows.
Mammography AI company with FDA-cleared cmTriage worklist-prioritization software and investigational or region-specific breast-screening tools.
AI-guided ultrasound software from GE HealthCare that helps clinicians acquire cardiac views and supports ultrasound measurements on compatible systems.
Handheld ultrasound platform with AI-supported workflows, including FDA-cleared iQ3 hardware and a cleared blind-sweep gestational-age AI tool.
Dental radiology AI platform for identifying and presenting findings in dental X-rays and CBCT workflows.
Dental AI platform combining radiograph analysis, image enhancement, practice workflows, payer workflows, and patient communication.
Dental AI platform with Clinical Assist for FDA-cleared radiographic findings plus practice workflow products.
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