{"product_name":"QuantX","company_name":"Quantitative Insights","product_url":"https://quantinsights.com","company_url":"https://quantinsights.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0611","summary":"QuantX is an FDA-cleared AI-driven software platform that assists radiologists in evaluating breast MRI images, enhancing diagnostic accuracy and efficiency.","description":"QuantX is a computer-aided diagnosis (CADx) system developed by Quantitative Insights, Inc., utilizing machine learning to analyze breast MRI images. It automates lesion segmentation and compares findings to a database of known cases, providing a QI Score to aid in diagnosis. The platform aims to improve radiologists' confidence, reduce costs, and enhance patient outcomes. It received FDA clearance in July 2017 and incorporates technology licensed from the University of Chicago's research labs.","categories":["clinical Care","imaging Software","radiology","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","Clinical","Diagnostic Imaging","Radiology","Artificial Intelligence","Medical Devices"],"market_segment":["Enterprise","Healthcare Institutions","Medical Imaging Centers"],"target_users":["Radiologists","Medical Imaging Professionals","Healthcare Providers"],"specialties":["Breast Imaging","Radiology","Medical Imaging","Oncology"],"regions_available":["United States","International"],"languages_supported":["English"],"pricing_model":"Enterprise_Quote","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"2010","deployment_model":["SaaS"],"os_platforms":["Web","iOS","Android"],"features":["AI-powered medical imaging analysis","Automated detection of anomalies","Quantitative assessment of imaging data","Integration with existing PACS systems","Real-time image processing","User-friendly interface","Cloud-based storage and access","Regulatory compliance with FDA 510(k) clearance","Continuous software updates and improvements","Secure data transmission and storage","Scalable architecture for healthcare institutions","Customizable reporting tools","Multi-language support","Patient data anonymization","Clinical decision support tools","Integration with electronic health records (EHR)","Remote access capabilities","Audit trails for user activity","Data visualization tools","Collaboration features for medical teams"],"optional_modules":["Advanced 3D imaging analysis","Integration with laboratory information systems (LIS)","Mobile app for patient engagement","Telemedicine integration","Predictive analytics for disease progression","Patient outcome tracking","Clinical trial support tools","Integration with wearable health devices","Natural language processing for medical records","Voice command functionality"],"integrations":["PACS","EHR","LIS","Wearable health devices","Laboratory information systems","Telemedicine platforms","Clinical trial management systems","Mobile health applications","Voice recognition systems","Cloud storage services"],"data_standards":["DICOM","HL7 v2","FHIR","SNOMED CT","ICD-10","LOINC","CPT","ICD-9","NDC","RxNorm"],"api_available":"yes","system_requirements":"Web browser, iOS or Android device","compliance":["HIPAA","FDA 510(k)","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP","Secure data transmission","Data anonymization","Access controls","Regular security updates"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","Data residency options","User data access controls","Data retention policies","Data breach notification procedures","Third-party audits","Privacy impact assessments"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0611","slug":"quantx","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/quantx.json"}}