{"product_name":"TumorSight Viz","company_name":"SimBioSys","product_url":"https://simbiosys.com/products/tumorsight-viz","company_url":"https://simbiosys.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0137","summary":"TumorSight Viz is an FDA-cleared, AI-powered software that transforms breast MRI scans into detailed 3D visualizations, aiding surgeons in precise preoperative planning for breast cancer surgeries.","description":"TumorSight Viz utilizes standard breast MRI images to generate 3D spatial visualizations of breast cancer, providing key metrics such as tumor volume, tumor-to-breast volume, and distances to anatomical structures. This assists surgeons in making informed decisions regarding breast-conserving surgery or mastectomy options. The software integrates seamlessly with hospital PACS systems, streamlining workflow and enhancing surgical precision. It has received multiple FDA 510(k) clearances, with the latest in July 2025, and is available for clinical use in the United States. TumorSight Viz is developed by SimBioSys, a clinical AI company specializing in precision medicine for cancer care.","categories":["clinical Care","diagnostic Support","patient Facing","Clinical","Diagnostic","Patient-facing"],"market_segment":["enterprise"],"target_users":["clinicians","surgeons","patients"],"specialties":["Breast Cancer"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2020","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["3D spatial visualization of breast cancer using DCE MRI","Automatic tumor segmentation with AI","Accurate volume measurements for pre-surgical planning","Tumor-to-landmark measurements for surgical decision-making","Conversion of prone MRI to supine position for enhanced visualization"],"optional_modules":["Clinical Decision Support (CDS) application"],"integrations":["PACS systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["End-to-end encryption","Secure data storage"],"privacy_features":["Data anonymization","Compliance with healthcare privacy regulations"],"data_residency":"US","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0137","slug":"tumorsight-viz","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/tumorsight-viz.json"}}