{"product_name":"SubtleMR","company_name":"Subtle Medical","product_url":"https://subtlemic.com/products/subtlemr","company_url":"https://subtlemic.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0354","summary":"SubtleMR is an AI-powered software developed by Subtle Medical that enhances MRI image quality by reducing noise and increasing sharpness, applicable across various body regions and compatible with all MRI scanners.","description":"SubtleMR utilizes deep learning algorithms to improve MRI images by denoising and enhancing resolution, applicable to all body regions and compatible with all MRI scanners, enhancing image quality and patient comfort.","categories":["clinical Care","diagnostic Support","imaging Software","Clinical","Diagnostic","Imaging Enhancement"],"market_segment":["enterprise","smb"],"target_users":["radiologists","MRI technologists","healthcare administrators"],"specialties":["Neurology","Orthopedics","Oncology","Cardiology","Musculoskeletal","Abdominal","Pelvic","Breast","Spinal","Vascular","Pediatric","Gastroenterology","Urology","Gynecology","Pulmonology","Endocrinology","Rheumatology","Infectious Disease","Immunology","Dermatology"],"regions_available":["United States","Canada","European Union","Australia","Japan","South Korea","China","India","Brazil","Mexico","South Africa","Russia","Saudi Arabia","United Arab Emirates","Singapore","Malaysia","Thailand","Indonesia","Philippines","Vietnam","Argentina"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Germany","India","China","Brazil","South Africa","Russia","Saudi Arabia","United Arab Emirates","Singapore"],"company_founding":"2017","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-powered medical imaging enhancement","Improved scan efficiency","Enhanced image quality","Radiology workflow optimization","Increased scanner sustainability","Elevated patient care"],"optional_modules":["SubtleMR","SubtlePET","SubtleGAD","SubtleCT","SubtleUS","SubtleXR","SubtleCT-IR","SubtleMR-IR","SubtlePET-IR","SubtleGAD-IR"],"integrations":["PACS","RIS","EMR/EHR systems","DICOM-compatible devices","HL7 interfaces","FHIR APIs","Cloud storage services","Third-party analytics platforms","Vendor-neutral archives","Medical imaging software"],"data_standards":["DICOM","HL7 v2","FHIR","ISO 13485:2016","ISO/IEC 42001:2023","MDSAP","MDR 2017/745","ISO 14971:2019","IEC 62304:2006"],"api_available":"yes","system_requirements":"","compliance":["HIPAA","GDPR","SOC 2 Type II","ISO 27001","ISO 27017","ISO 27018","PCI DSS","ISO 14971:2019","IEC 62304:2006","ISO/IEC 42001:2023","MDSAP","MDR 2017/745"],"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","SSO/SAML","Audit logs","2FA","DLP","SOC 2 Type II","ISO 27001","ISO 27017","ISO 27018"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization","GDPR compliance","HIPAA compliance","ISO 27001","ISO 27017","ISO 27018","PCI DSS"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0354","slug":"subtlemr","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/subtlemr.json"}}