{"product_name":"SubtleHD","company_name":"Subtle Medical","product_url":"https://subtlemedical.com/subtlehd","company_url":"https://subtlemedical.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0100","summary":"SubtleHD is an AI-powered software by Subtle Medical that enhances MRI image quality and reduces scan times by up to 80%, integrating seamlessly with existing MRI scanners.","description":"SubtleHD utilizes advanced denoising and sharpening techniques to produce ultra-clear MRI images, enabling significantly faster scan protocols. It integrates with existing MRI scanners from all major manufacturers, enhancing performance without requiring new hardware investments. The software is applicable to all body parts and MRI sequences, improving diagnostic confidence and patient comfort by reducing scan durations.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","imaging centers","hospitals"],"specialties":["Neurology","Orthopedics","Cardiology","Oncology","Musculoskeletal","Spine","Pediatrics","Gastroenterology","Urology","Gynecology","Pulmonology","Ent","Vascular","Trauma","Sports Medicine","Rheumatology","Infectious Disease","Endocrinology","Dermatology","Hematology"],"regions_available":["United States","Canada","European Union","Brazil","Chile","Mexico","Argentina","Colombia","Peru","Venezuela","Ecuador","Guatemala","Cuba","Bolivia","Dominican Republic","Honduras","Paraguay","El Salvador","Nicaragua","Costa Rica"],"languages_supported":["English","Spanish","Portuguese","French","German","Italian","Dutch","Swedish","Danish","Norwegian","Finnish","Polish","Czech","Hungarian","Romanian","Bulgarian","Greek","Turkish","Arabic","Chinese","Japanese"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","Italy","Spain","Brazil","Chile","Mexico"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Windows","macOS","Linux"],"features":["MRI image enhancement","AI-powered denoising and sharpening","Up to 80% reduction in scan times for certain sequences","Vendor-neutral compatibility with all MRI scanners","Integration into existing clinical workflows","Extended MRI scanner lifespan","Improved patient throughput","Enhanced patient comfort","Workflow automation"],"optional_modules":["SubtleSYNTH","SubtleALIGN"],"integrations":["MRI scanners","Hospital information systems","Electronic health record platforms"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","ISO 13485:2016","ISO/IEC 42001:2023","MDSAP","MDR 2017/745","ISO 14971:2019","IEC 62304:2006"],"certifications":["FDA 510(k)","CE/MDR","ISO 13485:2016","ISO/IEC 42001:2023","MDSAP","MDR 2017/745","ISO 14971:2019","IEC 62304:2006"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"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":"SW0100","slug":"subtlehd","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/subtlehd.json"}}