{"product_name":"OncoStudio","company_name":"Oncosoft","product_url":"https://www.oncosoft.io/products-eng","company_url":"https://www.oncosoft.io","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0089","summary":"OncoStudio is an AI-driven software developed by Oncosoft that automates organ contouring in radiation therapy, enhancing precision and efficiency in treatment planning.","description":"OncoStudio utilizes artificial intelligence to automatically detect treatment areas and prepare organ contours, significantly reducing manual effort and time in radiation therapy planning. It supports a comprehensive library of anatomical structures and integrates seamlessly with existing medical imaging systems, adhering to global standards like DICOM and HL7 FHIR. The software has been implemented in over 30 hospitals in South Korea, including Samsung Medical Center and Seoul National University Hospital, and is expanding its presence internationally, with plans to enter the U.S. and Japan markets in 2024. OncoStudio has received regulatory approval in South Korea and is recognized for its high accuracy and speed in contouring tasks, with processing times ranging from several seconds to a few minutes, depending on the complexity of the case. The company, Oncosoft, was founded in 2019 and is headquartered in Seoul, South Korea, with an office in Dallas, Texas, USA.","categories":["clinical Care","diagnostic Support","administrative Operations","Clinical","Diagnostic","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","medical physicists","radiation oncologists","admins"],"specialties":["Radiology","Oncology","Radiation Oncology"],"regions_available":["South Korea","United States","Japan"],"languages_supported":["Korean","English","Japanese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["South Korea","United States"],"company_founding":"2019","deployment_model":["on_prem","SaaS (planned for 2026)"],"os_platforms":["Windows","Linux","macOS"],"features":["AI-powered automatic organ and tissue recognition","Automatic detection of treatment areas","Preparation of organ contour samples without user input","Extensive structure library for various organs","Clinical-grade precision in contouring","Fast processing with contours drawn within an average of 1 minute per case","Integration with existing clinical workflows"],"optional_modules":["Cloud-based deployment (planned for 2026)"],"integrations":["DICOM","HL7 FHIR"],"data_standards":["DICOM","HL7 FHIR"],"api_available":"unknown","system_requirements":"Windows, Linux, macOS","compliance":["HIPAA","FDA 510(k) clearance","ISO 27001","SOC 2","GDPR","HITECH"],"certifications":["FDA 510(k) clearance","ISO 27001","SOC 2","GDPR","HITECH"],"security_features":["Encryption","RBAC","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0089","slug":"oncostudio","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/oncostudio.json"}}