{"product_name":"Volpara Imaging Software","company_name":"Volpara Health","product_url":"https://www.volparahealth.com/volpara-imaging-software","company_url":"https://www.volparahealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0460","summary":"Volpara Imaging Software is an AI-powered solution that enhances breast cancer screening by providing precise breast tissue quantification and optimizing mammogram quality, positioning, compression, and dose.","description":"Volpara Imaging Software leverages artificial intelligence to assist radiologists in accurately assessing breast density and improving mammogram quality. It integrates with various imaging systems and supports personalized breast care decisions, aiming to reduce advanced-stage breast cancer incidence.","categories":["clinical Care","diagnostic Support","administrative Operations","Clinical","Diagnostic","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","technologists","patients"],"specialties":["Radiology","Oncology"],"regions_available":["United States","Canada","Australia","New Zealand","Europe","Asia","South America","Africa"],"languages_supported":["English","Spanish","French","German","Italian","Dutch","Portuguese","Japanese","Chinese","Korean","Arabic","Russian","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["New Zealand","United States","Australia","United Kingdom","Germany","France","Italy","Spain","Netherlands","Japan"],"company_founding":"2009","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated patient positioning assessment","Volumetric approach to image evaluation","Standardization of mammographic image quality","Improvement of technologists' positioning performance","Preparation for external quality audits"],"optional_modules":["VolparaEnterprise Analytics"],"integrations":["PACS","Clinical Information Systems (CIS)","Radiology Information Systems (RIS)"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"DICOM-compatible PACS; typical PACS/server environment","compliance":["HIPAA","GDPR","SOC 2","ISO 27001","ISO 27017","ISO 27018","ISO 27701","SOC 2 Type 2","PCI DSS v4.0.1","Cyber Essentials","TX-RAMP"],"certifications":["FDA 510(k)","CE Mark","ISO 27001","ISO 27017","ISO 27018","ISO 27701","SOC 2 Type 2","PCI DSS v4.0.1","Cyber Essentials","TX-RAMP"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","OAuth 2.0","OpenID Connect","API rate limiting","Mutual TLS authentication"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data residency controls","Automated policy enforcement","Incident response and disaster recovery measures"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0460","slug":"volpara-imaging-software","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/volpara-imaging-software.json"}}