{"product_name":"Radiomics App v1.0","company_name":"Microsoft","product_url":"https://www.microsoft.com/en-us/ai/ai-lab-radiomics","company_url":"https://www.microsoft.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0603","summary":"Microsoft's Radiomics App v1.0 is an FDA-cleared software designed to analyze medical imaging data for enhanced diagnostic insights.","description":"Radiomics App v1.0 utilizes machine learning algorithms to extract quantitative features from medical images, aiding in the detection and characterization of diseases, particularly cancers. It received FDA clearance on December 27, 2017, under 510(k) number K173420, indicating its substantial equivalence to existing devices in the market. The app is intended for use by healthcare professionals to support clinical decision-making processes.","categories":["clinical Care","diagnostic Support","imaging Software","Clinical","Diagnostic","Image Analysis"],"market_segment":["enterprise","consumer"],"target_users":["clinicians","radiologists","oncologists"],"specialties":["Oncology","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"contact vendor","pricing_details":"Pricing details are not publicly disclosed; interested parties should contact Microsoft for more information.","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","India","China","Japan","Australia","Brazil"],"company_founding":"1975","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Medical image analysis","Data visualization","Predictive modeling","Clinical decision support","Patient outcome prediction","Integration with imaging devices","Data preprocessing","Feature extraction","Model training","Model validation","Result interpretation","Reporting tools","User management","Audit trails","Data security","Compliance tracking","Collaboration tools","Customizable workflows","Scalability","Interoperability"],"optional_modules":["Advanced analytics","AI model development","Cloud storage integration","Data anonymization","Real-time monitoring","Automated reporting","Patient data management","Clinical trial support","Regulatory compliance tools","Data visualization enhancements"],"integrations":["PACS","DICOM","HL7","FHIR","Epic","Cerner","Meditech","Allscripts","GE Healthcare","Siemens Healthineers","Philips Healthcare","Canon Medical Systems","Agfa HealthCare","IBM Watson Health","Oracle Health Sciences","McKesson","Nuance Communications","Zebra Medical Vision","Arterys","Viz.ai"],"data_standards":["DICOM","HL7","FHIR","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","NDC","RxNorm"],"api_available":"yes","system_requirements":["Windows Server 2016 or later","Linux (Ubuntu 18.04 or later)","macOS Mojave or later","8 GB RAM","2.5 GHz processor","500 GB storage","GPU with CUDA support (for AI processing)"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001","ISO 13485","FDA 21 CFR Part 11","FDA 510(k)","CE Marking","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17"],"certifications":["FDA 510(k)","CE Marking","ISO 13485","ISO 9001","ISO 27001","ISO 27018","ISO 27799","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","Firewall","Intrusion detection","Data masking","Access controls"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data retention policies","Data access controls","Data sharing policies","Data breach notification","Data subject rights management","Data processing agreements"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0603","slug":"radiomics-app-v1-0","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/radiomics-app-v1-0.json"}}