JSON twin: https://www.healthaidb.com/software/airascore-structure.json
AIRAmed
https://arzt.airamed.de/en/airascore-structure
AI-based MR brain volumetry and segmentation software that quantifies brain structures, white matter hyperintensities and compares results to age‑ and sex‑matched norms to support early detection and monitoring of neurodegenerative disease.
AIRAscore structure (AIRAmed) performs automatic segmentation and volume quantification from 3D T1 and T2 FLAIR MR images, generates PDF/DICOM reports and overlays, provides normative (age/sex/head‑size) comparisons, traffic‑light visualisations and PACS integration. Deployment options include cloud, hybrid and local virtualised installations; cleared via CE (MDD Class I) and FDA 510(k) (Class II).
unknown
2019
Hosted in Germany (German-only hosting option)
P2008
2025-09-07
commercial proprietary
contact vendor
enterprise_quote
2020
Local PACS-node client; accepts T1 DICOM MR (1.5T/3T) with voxel size ≤2.4 mm³; encrypted network connection to AIRAmed servers
product
1.0
{ "company_name": "AIRAmed", "company_url": "https://www.airamed.de/en/", "company_offices": [ "Germany" ], "company_founding": "2019", "product_url": "https://arzt.airamed.de/en/airascore-structure", "categories": [ "clinical", "diagnostic", "imaging", "radiology", "neuroradiology", "AI" ], "market_segment": [ "enterprise", "hospitals", "clinics" ], "links": [ "https://www.airamed.de/en/home", "https://arzt.airamed.de/en/airascore-structure", "https://patient.airamed.de/en/airascore-structure", "https://healthairegister.com/products/airamed-airascore-structure", "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223180.pdf", "https://www.biospace.com/airamed-receives-fda-510-k-clearance-for-its-airascore-brain-volumetry-software", "https://practicalneurology.com/news/ai-based-software-for-detecting-brain-volumetric-changes-receives-fda-510k-clearance/2470303/", "https://www.nature.com/articles/s41598-022-25545-z", "https://www.linkedin.com/company/airamed-gmbh" ], "summary": "AI-based MR brain volumetry and segmentation software that quantifies brain structures, white matter hyperintensities and compares results to age‑ and sex‑matched norms to support early detection and monitoring of neurodegenerative disease.", "description": "AIRAscore structure (AIRAmed) performs automatic segmentation and volume quantification from 3D T1 and T2 FLAIR MR images, generates PDF/DICOM reports and overlays, provides normative (age/sex/head‑size) comparisons, traffic‑light visualisations and PACS integration. Deployment options include cloud, hybrid and local virtualised installations; cleared via CE (MDD Class I) and FDA 510(k) (Class II).", "target_users": [ "radiologists", "neurologists", "neuroradiologists", "clinicians", "radiology IT/admins", "researchers" ], "specialties": [ "neurology", "neuroradiology", "dementia care", "Alzheimer's disease", "multiple sclerosis", "movement disorders/Parkinson's disease", "psychiatry" ], "regions_available": [ "Germany", "European Union", "United States" ], "languages_supported": [ "English", "German" ], "pricing_model": "enterprise_quote", "pricing_details": "contact vendor", "license": "commercial proprietary", "deployment_model": [ "cloud (SaaS)", "local client (PACS-node)", "hybrid" ], "os_platforms": [ "PACS/DICOM node (Windows/Linux server)", "Web (report access via PACS/PDF)" ], "features": [ "Automated brain segmentation (gray matter, white matter, CSF, T1 hypointensities)", "Quantitative brain volumetry (global and regional)", "Comparison with age-/gender-matched healthy reference population", "Hippocampal volume measurement and atrophy assessment", "Co-registered segmentation overlays for visual validation", "PDF evaluation report returned to PACS", "Traffic-light / easy-interpretation indicators", "Processing within minutes (rapid turnaround)", "Pseudonymization of DICOM headers before transmission", "Support for Siemens/Philips/GE MR datasets (1.5T/3T, T1) " ], "optional_modules": [], "integrations": [ "PACS (via local PACS-node client)", "DICOM MR Image IOD ingestion", "Siemens MRI", "Philips MRI", "GE MRI", "Radiology reporting workflow (PDF into PACS)" ], "data_standards": [ "DICOM" ], "api_available": "unknown", "system_requirements": "Local PACS-node client; accepts T1 DICOM MR (1.5T/3T) with voxel size ≤2.4 mm³; encrypted network connection to AIRAmed servers", "compliance": [ "GDPR" ], "certifications": [ "FDA 510(k) K223180", "CE (medical device - marketed in Europe)" ], "security_features": [ "Encrypted transmission (TLS)", "Pseudonymization of DICOM headers prior to transfer", "Server-hosted processing in Germany" ], "privacy_features": [ "Pseudonymization of patient identifiers before transmission", "Only age and gender transmitted for reference comparison", "Privacy/GDPR-focused hosting and policies" ], "data_residency": "Hosted in Germany (German-only hosting option)", "customers": [ "University Hospital of Tübingen", "Private radiology practices in Stuttgart", "Radiology practice in Hamburg", "Radiology practice in Sindelfingen", "Hospitals and clinics using PACS integrations (unnamed)" ], "user_reviews": [ "Especially in the case of rare neurological diseases, we are often faced with the problem of whether an individual brain scan is already conspicuous or not. AIRAscore provides great help in our daily work.", "With AIRAscore structure, I can support my diagnosis and diagnose changes in brain volume that I would only have been able to detect much later with a purely visual assessment. This added value pleases my patients, but also me as a doctor.", "I am pleased to be able to offer my patients the additional service provided by AIRAscore. Experience shows that very many patients are afraid of dementia in old age. AIRAscore helps me to distinguish healthy from sick aging and I recognize much earlier than with the pure visual findings whether and when concrete action is needed.", "I am pleased that with AIRAscore structure we now have a way to benefit from the latest scientific findings in our private practice. It only takes a few minutes until I have exact measurement values directly in my PACS, which significantly improve my reporting options.", "We now use AIRAscore structure routinely with our inpatients. The findings report gives us the necessary security here in the assessment of dementia-related diseases." ], "ratings": [ "FDA 510(k) cleared — K223180 (U.S. Food and Drug Administration)", "CE marked (MDD, Class I) — verified by Health AI Register", "Listed on Radiology / Health AI Register (product page)" ], "support_channels": [ "email", "phone", "contact form", "website inquiry" ], "training_options": [ "documentation", "downloads", "live_online (remote onboarding)", "onsite (installation support)", "webinars" ], "release_year": "2020", "integration_partners": [ "PACS (standard reading environment, DICOM integration)", "DICOM", "Virtual machine (VM) deployment", "Docker", "Hybrid / Cloud deployment", "Johner Institut (FDA correspondence/consultancy listed in 510(k) filing)" ], "id": "P2008", "slug": "airascore-structure", "type": "product", "version": "1.0", "last_updated": "2025-09-07", "links_json": { "self": "https://www.healthaidb.com/software/airascore-structure.json" } }