{"product_name":"HealthMammo","company_name":"Zebra Medical Vision","product_url":"https://www.zebra-med.com/healthmammo","company_url":"https://www.zebra-med.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0503","summary":"HealthMammo is an AI-driven tool that assists radiologists in prioritizing and identifying suspicious findings in 2D mammograms, enhancing early breast cancer detection.","description":"HealthMammo is an AI-based software developed by Zebra Medical Vision to analyze 2D full-field digital mammograms, flagging suspicious findings to aid radiologists in prioritizing cases. It integrates with existing radiology workflows, providing passive notifications within the PACS/worklist to improve efficiency without replacing diagnostic evaluation. The tool has received FDA 510(k) clearance and a CE mark, demonstrating its regulatory compliance and readiness for clinical use.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","healthcare providers"],"specialties":["Oncology","Radiology"],"regions_available":["United States","Europe"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Israel","United States","Europe"],"company_founding":"2014","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Automated AI analysis of 2D mammograms","Prioritization and detection of suspicious mammograms","Integration with PACS systems","Support for breast radiologists in reading and reporting workflows","FDA 510(k) clearance for mammography solution","CE mark approval in Europe","Part of Zebra Medical's AI1 (All-In-One) bundle","Processing and analysis of suspected breast lesions","Signal notifications within worklist or dedicated application","Improved patient care through comprehensive reporting","Enhanced diagnostic accuracy for breast cancer detection","Real-time analysis of mammography images","Seamless integration with existing radiology workflows","Scalable deployment across multiple healthcare facilities","Continuous updates and improvements to AI algorithms","User-friendly interface for radiologists","Secure handling of patient data","Compliance with healthcare data security standards","Support for various mammography equipment vendors","Ability to handle large volumes of mammography data"],"optional_modules":["Advanced analytics dashboard","Integration with electronic health records (EHR)","Support for 3D mammography images","Automated reporting generation","Integration with other imaging modalities","Patient management features","Clinical decision support tools","Integration with telemedicine platforms","Mobile application for radiologists","Cloud-based storage solutions"],"integrations":["PACS systems","Electronic health records (EHR)","Mammography equipment vendors","Telemedicine platforms","Cloud-based storage solutions","Other imaging modalities","Patient management systems","Clinical decision support systems","Mobile applications for radiologists","Third-party analytics platforms"],"data_standards":["DICOM","HL7","FHIR","ICD-10","SNOMED CT","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"yes","system_requirements":"","compliance":["HIPAA","GDPR","FDA 510(k)","CE mark","ISO 13485","ISO 14971","ISO 27001","SOC 2 Type 2","HITECH","FDA 21 CFR Part 820"],"certifications":["FDA 510(k)","CE mark","ISO 13485","ISO 14971","ISO 27001","SOC 2 Type 2","FDA 21 CFR Part 820","ISO 9001","ISO 14001","ISO 45001"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","Secure data transmission","Data anonymization","Access controls","Regular security assessments"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data residency options","Data access controls","Data retention policies","User data rights management","Compliance with data protection laws","Regular privacy audits"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0503","slug":"healthmammo","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/healthmammo.json"}}