SubtleMR

JSON twin: https://www.healthaidb.com/software/subtlemr.json

Company Name

Subtle Medical

Product URL

https://subtlemic.com/products/subtlemr

Company URL

https://subtlemic.com

Categories

• clinical Care
• diagnostic Support
• imaging Software
• Clinical
• Diagnostic
• Imaging Enhancement

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.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ISO 13485:2016
• ISO/IEC 42001:2023
• MDSAP
• MDR 2017/745
• ISO 14971:2019
• IEC 62304:2006

Company Founding

2017

Company Offices

• United States
• Germany
• India
• China
• Brazil
• South Africa
• Russia
• Saudi Arabia
• United Arab Emirates
• Singapore

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

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7 v2
• FHIR
• ISO 13485:2016
• ISO/IEC 42001:2023
• MDSAP
• MDR 2017/745
• ISO 14971:2019
• IEC 62304:2006

Deployment Model

• SaaS

Features

• AI-powered medical imaging enhancement
• Improved scan efficiency
• Enhanced image quality
• Radiology workflow optimization
• Increased scanner sustainability
• Elevated patient care

Id

SW0354

Integration Partners

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

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• SubtleMR
• SubtlePET
• SubtleGAD
• SubtleCT
• SubtleUS
• SubtleXR
• SubtleCT-IR
• SubtleMR-IR
• SubtlePET-IR
• SubtleGAD-IR

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• GDPR compliance
• HIPAA compliance
• ISO 27001
• ISO 27017
• ISO 27018
• PCI DSS

Product Code

SW0354

Product Name

SubtleMR

Ratings

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

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• SOC 2 Type II
• ISO 27001
• ISO 27017
• ISO 27018

Specialties

• Neurology
• Orthopedics
• Oncology
• Cardiology
• Musculoskeletal
• Abdominal
• Pelvic
• Breast
• Spinal
• Vascular
• Pediatric
• Gastroenterology
• Urology
• Gynecology
• Pulmonology
• Endocrinology
• Rheumatology
• Infectious Disease
• Immunology
• Dermatology

Support Channels

System Requirements

Target Users

• radiologists
• MRI technologists
• healthcare administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}