Thyroid Ultrasound AI

JSON twin: https://www.healthaidb.com/software/thyroid-ultrasound-ai.json

Company Name

See-Mode Technologies

Product URL

https://www.see-mode.com/thyroid-ultrasound-ai

Company URL

https://www.see-mode.com

Categories

• clinical Care
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• radiology
• healthcare Software Solutions
• healthcare It
• medical Device
• regulatory Compliance
• Clinical
• Diagnostic Imaging
• Artificial Intelligence
• Medical Imaging
• Ultrasound Imaging
• Medical Software
• Medical Devices

Summary

See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software that automates the detection and classification of thyroid nodules, streamlining reporting and enhancing diagnostic accuracy.

Description

See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software solution that automates the detection and classification of thyroid nodules in ultrasound images. It aligns with the American College of Radiology's (ACR) TI-RADS rating system, generating complete worksheets and preliminary impressions for radiologists. The software aims to reduce reporting time and inter-operator variability, improving diagnostic efficiency and accuracy. It also facilitates easy comparison between previous and new images, aiding in the assessment of nodule changes over time. The product is the first FDA-cleared device for both detection and diagnosis (CADe/x) of thyroid ultrasound, offering a high level of automation without manual user input. Clinicians can review and amend AI outputs before finalizing reports, streamlining the reporting of follow-up thyroid studies. A multi-reader multi-case (MRMC) study demonstrated that See-Mode enhanced radiologists' performance in nodule localization, characterization, and ACR TI-RADS level agreement, leading to improved differentiation between benign and malignant thyroid nodules.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark

Company Founding

2018

Company Offices

• Australia
• Singapore
• United States
• Canada
• New Zealand

Compliance

• FDA 510(k) clearance
• CE Mark
• HIPAA
• GDPR

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• TI-RADS

Deployment Model

• SaaS
• on_prem

Features

• Automatic detection and characterization of thyroid nodules
• Alignment with ACR TI-RADS rating system
• Generation of standardized ultrasound worksheets
• Pre-population of radiologist report templates
• Facilitation of follow-up examinations with change detection
• Reduction of reporting time and inter-operator variability

Id

SW0166

Integration Partners

Integrations

• PACS
• RIS
• Radiology reporting systems

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

Os Platforms

• Web
• Windows

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Customer portal consent management
• Data transfer notifications (EU→US disclosures)

Product Code

SW0166

Product Name

Thyroid Ultrasound AI

Ratings

Regions Available

• United States
• Canada
• Australia
• New Zealand
• Singapore

Related Urls

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

Release Year

Security Features

• Encrypted connections (TLS)
• Role-based access controls
• Audit logging

Specialties

• Endocrinology
• Radiology
• Oncology
• Internal Medicine
• Family Medicine
• Otolaryngology
• Surgery
• Pathology
• Nuclear Medicine
• Preventive Medicine
• Geriatrics
• Pediatrics
• Obstetrics And Gynecology
• Emergency Medicine
• Orthopedics
• Neurology
• Cardiology
• Pulmonology
• Gastroenterology
• Nephrology

Support Channels

System Requirements

Web browser; Windows OS for on-prem deployment

Target Users

• Clinicians
• Radiologists
• Sonographers
• Healthcare Administrators
• Medical Imaging Professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Thyroid Ultrasound AI",
  "company_name": "See-Mode Technologies",
  "product_url": "https://www.see-mode.com/thyroid-ultrasound-ai",
  "company_url": "https://www.see-mode.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0166",
  "summary": "See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software that automates the detection and classification of thyroid nodules, streamlining reporting and enhancing diagnostic accuracy.",
  "description": "See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software solution that automates the detection and classification of thyroid nodules in ultrasound images. It aligns with the American College of Radiology's (ACR) TI-RADS rating system, generating complete worksheets and preliminary impressions for radiologists. The software aims to reduce reporting time and inter-operator variability, improving diagnostic efficiency and accuracy. It also facilitates easy comparison between previous and new images, aiding in the assessment of nodule changes over time. The product is the first FDA-cleared device for both detection and diagnosis (CADe/x) of thyroid ultrasound, offering a high level of automation without manual user input. Clinicians can review and amend AI outputs before finalizing reports, streamlining the reporting of follow-up thyroid studies. A multi-reader multi-case (MRMC) study demonstrated that See-Mode enhanced radiologists' performance in nodule localization, characterization, and ACR TI-RADS level agreement, leading to improved differentiation between benign and malignant thyroid nodules.",
  "categories": [
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  "market_segment": [
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  "target_users": [
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    "Sonographers",
    "Healthcare Administrators",
    "Medical Imaging Professionals"
  ],
  "specialties": [
    "Endocrinology",
    "Radiology",
    "Oncology",
    "Internal Medicine",
    "Family Medicine",
    "Otolaryngology",
    "Surgery",
    "Pathology",
    "Nuclear Medicine",
    "Preventive Medicine",
    "Geriatrics",
    "Pediatrics",
    "Obstetrics And Gynecology",
    "Emergency Medicine",
    "Orthopedics",
    "Neurology",
    "Cardiology",
    "Pulmonology",
    "Gastroenterology",
    "Nephrology"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Australia",
    "New Zealand",
    "Singapore"
  ],
  "languages_supported": [
    "English"
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  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Australia",
    "Singapore",
    "United States",
    "Canada",
    "New Zealand"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem"
  ],
  "os_platforms": [
    "Web",
    "Windows"
  ],
  "features": [
    "Automatic detection and characterization of thyroid nodules",
    "Alignment with ACR TI-RADS rating system",
    "Generation of standardized ultrasound worksheets",
    "Pre-population of radiologist report templates",
    "Facilitation of follow-up examinations with change detection",
    "Reduction of reporting time and inter-operator variability"
  ],
  "optional_modules": [],
  "integrations": [
    "PACS",
    "RIS",
    "Radiology reporting systems"
  ],
  "data_standards": [
    "DICOM",
    "TI-RADS"
  ],
  "api_available": "unknown",
  "system_requirements": "Web browser; Windows OS for on-prem deployment",
  "compliance": [
    "FDA 510(k) clearance",
    "CE Mark",
    "HIPAA",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark"
  ],
  "security_features": [
    "Encrypted connections (TLS)",
    "Role-based access controls",
    "Audit logging"
  ],
  "privacy_features": [
    "Customer portal consent management",
    "Data transfer notifications (EU→US disclosures)"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0166",
  "slug": "thyroid-ultrasound-ai",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/thyroid-ultrasound-ai.json"
  }
}