SubtleSYNTH

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

Company Name

Subtle Medical

Product URL

https://subtlemic.com/products/subtlesynth

Company URL

https://subtlemic.com

Categories

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

Summary

SubtleSYNTH is an AI-powered software by Subtle Medical that generates synthetic STIR MRI images from existing T1 and T2 weighted contrasts, reducing scan times and enhancing image quality.

Description

SubtleSYNTH utilizes deep learning to produce synthetic STIR images without additional acquisition time, complementing Subtle Medical's SubtleMR software. It has received FDA clearance for spinal imaging and is expanding to brain and musculoskeletal imaging. The technology aims to improve MRI efficiency and patient care by reducing scan durations and maintaining high image quality.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO/IEC 42001
• ISO 13485
• IEC 62304
• ISO 14971
• MDSAP
• MDR 2017/745

Company Founding

2017

Company Offices

• United States

Compliance

• HIPAA
• SOC 2 Type II
• ISO/IEC 42001
• FDA 510(k)
• CE Mark
• ISO 13485
• IEC 62304
• ISO 14971
• MDSAP
• MDR 2017/745

Customers

Data Residency

Global deployments with region options (US and EU hosting/enterprise on-prem appliance or hybrid deployments)

Data Standards

• DICOM
• HL7 v2
• IHE profiles

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-driven synthetic STIR image generation from T1 and T2 weighted contrasts
• Zero acquisition time for synthetic STIR images
• Interchangeability with conventionally acquired STIR images
• Validation for spinal imaging
• Complementary to SubtleMR™ for accelerated MRI procedures

Id

SW0198

Integration Partners

Integrations

• PACS
• DICOM
• Siemens MRI scanners
• GE MRI scanners
• Philips MRI scanners
• Hitachi MRI scanners

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Subtle-ELITE package bundling (SubtleHD, SubtleSYNTH, SubtleALIGN)

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• PHI access controls and audit trails
• Data minimization/anonymization options for research workflows

Product Code

SW0198

Product Name

SubtleSYNTH

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• TLS encryption in transit
• Encryption at rest
• Role-based access control (RBAC)
• Audit logging
• SSO/SAML support
• Two-factor authentication (2FA)

Specialties

• Spinal Imaging
• Brain Imaging
• Musculoskeletal Imaging

Support Channels

System Requirements

DICOM network connectivity to PACS; edge appliance runs on Linux; cloud SaaS option available; firewall/DICOM port access required

Target Users

• radiologists
• MRI technologists
• healthcare administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SubtleSYNTH",
  "company_name": "Subtle Medical",
  "product_url": "https://subtlemic.com/products/subtlesynth",
  "company_url": "https://subtlemic.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0198",
  "summary": "SubtleSYNTH is an AI-powered software by Subtle Medical that generates synthetic STIR MRI images from existing T1 and T2 weighted contrasts, reducing scan times and enhancing image quality.",
  "description": "SubtleSYNTH utilizes deep learning to produce synthetic STIR images without additional acquisition time, complementing Subtle Medical's SubtleMR software. It has received FDA clearance for spinal imaging and is expanding to brain and musculoskeletal imaging. The technology aims to improve MRI efficiency and patient care by reducing scan durations and maintaining high image quality.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "clinical Workflow Optimization",
    "Clinical",
    "Diagnostic",
    "Imaging Enhancement",
    "Workflow Optimization"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "MRI technologists",
    "healthcare administrators"
  ],
  "specialties": [
    "Spinal Imaging",
    "Brain Imaging",
    "Musculoskeletal Imaging"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-driven synthetic STIR image generation from T1 and T2 weighted contrasts",
    "Zero acquisition time for synthetic STIR images",
    "Interchangeability with conventionally acquired STIR images",
    "Validation for spinal imaging",
    "Complementary to SubtleMR™ for accelerated MRI procedures"
  ],
  "optional_modules": [
    "Subtle-ELITE package bundling (SubtleHD, SubtleSYNTH, SubtleALIGN)"
  ],
  "integrations": [
    "PACS",
    "DICOM",
    "Siemens MRI scanners",
    "GE MRI scanners",
    "Philips MRI scanners",
    "Hitachi MRI scanners"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "IHE profiles"
  ],
  "api_available": "yes",
  "system_requirements": "DICOM network connectivity to PACS; edge appliance runs on Linux; cloud SaaS option available; firewall/DICOM port access required",
  "compliance": [
    "HIPAA",
    "SOC 2 Type II",
    "ISO/IEC 42001",
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "IEC 62304",
    "ISO 14971",
    "MDSAP",
    "MDR 2017/745"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO/IEC 42001",
    "ISO 13485",
    "IEC 62304",
    "ISO 14971",
    "MDSAP",
    "MDR 2017/745"
  ],
  "security_features": [
    "TLS encryption in transit",
    "Encryption at rest",
    "Role-based access control (RBAC)",
    "Audit logging",
    "SSO/SAML support",
    "Two-factor authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "PHI access controls and audit trails",
    "Data minimization/anonymization options for research workflows"
  ],
  "data_residency": "Global deployments with region options (US and EU hosting/enterprise on-prem appliance or hybrid deployments)",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0198",
  "slug": "subtlesynth",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/subtlesynth.json"
  }
}