See-Mode Augmented Reporting Tool

by See-Mode Technologies Pte. Ltd.  · Based in Singapore → — AI-enhanced Thyroid & Breast ultrasound reporting
Endocrinology General Surgery Radiology

Not publicly available.
Regulatory Status Disclosed

Overview

The See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone, web-based image processing and reporting software designed to assist trained medical professionals in analyzing thyroid ultrasound images of adult patients (>=22 years old). It aims to reduce reporting time and variation in the delivery of care for thyroid ultrasound. The software automatically detects nodules in single or multinodular thyroid ultrasound images and classifies each nodule in line with the American College of Radiology’s (ACR) TI-RADS rating systems. A complete worksheet is automatically generated, and preliminary impressions are sent to radiology reporting systems after clinician review and approval. This automation includes detection and characterization of thyroid nodules without manual user input, while enabling clinicians to review and amend the AI outputs quickly before finalizing the report. The product also streamlines reporting of follow-up thyroid studies, addressing a significant pain point and time-consuming task for radiologists. See-Mode Technologies was acquired by RadNet, Inc. and is now part of its DeepHealth subsidiary, integrating its solutions into DeepHealth’s Population Health portfolio as the Thyroid Suite.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic nodule detection and characterization in ultrasound images
  • Classification of nodules according to ACR TI-RADS guidelines
  • Instant generation of complete ultrasound worksheets
  • Pre-population of radiologist report templates with examination findings and preliminary impressions
  • Streamlined reporting of follow-up thyroid studies
  • Web-based image processing and reporting software
  • Enhances diagnostic performance of radiologists in nodule localization, characterization, and TI-RADS level agreement
  • Reduces inter-operator variability and reporting errors
  • Seamless integration with existing clinical workflows (PACS/RIS)

Use Cases

  • Analyzing thyroid ultrasound images for nodule detection
  • Localizing and characterizing thyroid nodules
  • Generating structured reports for thyroid ultrasound examinations
  • Improving diagnostic accuracy for thyroid nodules
  • Streamlining workflow for sonographers and radiologists in thyroid ultrasound reporting
  • Facilitating efficient follow-up examinations for thyroid conditions

What Physicians Need to Know

Key Capabilities
Automated detection and characterization of nodules/lesions in thyroid and breast ultrasound images according to ACR TI-RADS and BI-RADS guidelines. Instantly generates complete ultrasound worksheets and pre-populates radiologist report templates. Facilitates easy comparison for follow-up examinations, highlighting changes. Also supports analysis and reporting of vascular ultrasound scans (AVA product) including vessel wall segmentation and Doppler velocity analysis.
Clinical Utility
Reduces reporting time and enhances consistency, improving diagnostic accuracy and efficiency. Mitigates inter-operator variability and reporting errors. Aids in localizing nodules/lesions and generating lexicon-based descriptors. Studies show improved diagnostic performance of radiologists in assessing nodule malignancy and characterization. Potential to reduce unnecessary biopsies and improve biopsy accuracy for thyroid studies, and detect malignancy in breast ultrasound. Demonstrated up to a 30% reduction in scan slot time for thyroid ultrasound.
Integration Options
Designed for seamless integration with existing workflows. Worksheets can be sent to PACS or RIS, and preliminary impressions are sent to radiology reporting systems (e.g., PowerScribe/Fluency). The software is web-based, runs on standard computers, and takes DICOM-compliant ultrasound images as input. See-Mode is now part of DeepHealth (a RadNet subsidiary), indicating integration within their broader health informatics solutions.
Compliance Status
FDA 510(k) cleared for Thyroid ultrasound analysis and reporting (SMART-T) and Augmented Vascular Analysis (AVA). Approved by Singapore Health Sciences Authority (HSA), Health Canada, ARTG (Australia), and MED SAFE (New Zealand). Commercially available in the US, Canada, Australia, New Zealand, and Singapore. The software is intended to assist trained medical professionals and not for independent medical advice or treatment decisions.
Pricing Model
Specific pricing details are not publicly disclosed, but it operates under a proprietary licensing model and is cloud-hosted/web-based. The availability of existing CPT codes for AI-based thyroid ultrasound analysis offers reimbursement opportunities. RadNet's acquisition of See-Mode suggests an enterprise-level licensing or acquisition model, with payments tied to implementation and regulatory clearances.
User Experience
Aims to streamline clinical workflows by automating sonographer tasks and simplifying radiologist interpretation. Described as human-centered and intuitive, eliminating tedious manual steps in image interpretation and reporting. Allows clinicians to quickly review and amend AI outputs before finalizing reports.
Support Quality
Offers chat support for software users, along with in-person and live online training.
Implementation Complexity
A stand-alone, web-based software accessible via a web browser on a standard computer, requiring no dedicated medical equipment beyond the ultrasound machine. Early deployments have demonstrated improved workflow efficiency. While integration into existing PACS/RIS/EMR systems can be a common challenge for AI tools, See-Mode is designed for seamless integration.
Evidence Base
Supported by multi-reader multi-case (MRMC) studies demonstrating improved diagnostic performance of radiologists in assessing thyroid nodule malignancy and characterization, including better assessment of TI-RADS descriptors. Studies also show it outperforms average reader performance for BI-RADS feature characteristics. Real-world deployment at RadNet imaging centers has shown improved workflow efficiency and enhanced diagnostic accuracy.
Physician Tip

Consider See-Mode Augmented Reporting Tool for its potential to significantly reduce reporting time and improve consistency in thyroid, breast, and vascular ultrasound interpretations. The AI-powered automation for nodule/lesion detection and characterization, coupled with instant worksheet generation and report pre-population, can free up valuable physician time. Its regulatory clearances (FDA, Health Canada, etc.) provide assurance of its clinical validation. However, remember that the software is an assistive tool; always review and approve AI outputs, as patient management decisions should not be based solely on its analysis. Evaluate its integration capabilities with your existing PACS/RIS/EMR to ensure a smooth workflow transition.

See-Mode is designed for seamless integration into existing radiology workflows. It can send generated worksheets to PACS or RIS and preliminary impressions to various radiology reporting systems (e.g., PowerScribe/Fluency). As a web-based, DICOM-compliant software, it aims to minimize disruption to current infrastructure. Its acquisition by RadNet and integration into DeepHealth's portfolio further suggests robust integration capabilities within larger healthcare IT ecosystems, focusing on operational efficiency and streamlined diagnostic workflows.

Details

Category Endocrinology & Metabolic AI, Oncology AI, Radiology & Imaging AI
Pricing Not publicly available.
DeploymentWeb-based software
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under K240697 on September 9, 2024, for its thyroid ultrasound analysis and reporting software. It is the first FDA-cleared product for both detection and diagnosis (CADe/x) of thyroid ultrasound.

Integrations
EHR Not specified
Specialties Endocrinology, General Surgery, Radiology

What the Web Says

See-Mode Augmented Reporting Tool is an AI-enhanced MedTech platform designed to improve diagnostic accuracy and efficiency in ultrasound reporting for thyroid and breast imaging. It automatically analyzes ultrasound images, detects and characterizes nodules and lesions, and generates comprehensive reports based on ACR TI-RADS and BI-RADS guidelines. The software aims to reduce manual data entry, inter-operator variability, and reporting errors, ultimately streamlining clinical workflows and enhancing diagnostic confidence.

Overall: Positive

Strengths

  • Reduces scan time and increases workflow efficiency (up to 30% reduction reported).
  • Enhances diagnostic accuracy and consistency in assessing nodule malignancy and characterization.
  • Automates detection, sizing, and characterization of thyroid nodules and breast lesions without manual user input.
  • Generates complete sonographer worksheets and pre-populates radiologist report templates.
  • Streamlines reporting of follow-up studies by highlighting changes in nodule size and characteristics.
  • FDA-cleared for both detection and diagnosis (CADe/x) of thyroid ultrasound.

Limitations

  • No specific negative reviews or opinions from physicians, healthcare IT, or tech reviewers were found in the search results.
  • No reviews or discussions about See-Mode Augmented Reporting Tool were found on Reddit, G2, or Capterra.

Based on reviews from: SourceForge, See-Mode Official Website, accessdata.fda.gov, DeepHealth (RadNet, Inc. Acquires See-Mode Technologies), AuntMinnie, PR Newswire, Blackford Analysis, YouTube

Last updated: 2026-07-20

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Press & Coverage

accessdata.fda.gov
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
This document is a 510(k) summary for the See-Mode Augmented Reporting Tool, Thyroid (SMART-T), a standalone, web-based image processing and reporting software designed to assist medical professionals in analyzing thyroid ultrasound images. It localizes nodules, generates lexicon-based descriptors, and classifies them according to ACR TI-RADS.
2024-09
GlobeNewswire
DeepHealth Unveils Industry's Most Comprehensive Portfolio of Native Clinical AI Solutions at ECR 2026
DeepHealth announced its expanded AI portfolio at ECR 2026, featuring the DeepHealth Thyroid AI, which is manufactured as See-Mode Augmented Reporting Tool, Thyroid (SMART-T) by See-Mode. This AI-powered solution automates nodule detection, characterization, measurements, and reporting within thyroid ultrasound workflows.
2026-03
Nasdaq (via GlobeNewswire)
DeepHealth Unveils Next-Generation Imaging Informatics and Clinical AI Solutions at RSNA 2025, Advancing a New Standard of AI-Powered Care
DeepHealth showcased its expanded portfolio at RSNA 2025, including the DeepHealth Thyroid AI (SMART-T), manufactured by See-Mode. The Thyroid Suite aims to streamline prostate MRI interpretation, analysis, and biopsy planning workflows, integrating automated lesion detection and risk classification.
2025-11
GlobeNewswire
GE HealthCare and RadNet's DeepHealth division sign Letter of Intent to advance innovation and adoption of AI-powered imaging across multiple modalities and remote scanning
GE HealthCare and DeepHealth announced an expanded collaboration to integrate GE HealthCare's ultrasound imaging with DeepHealth's AI-powered Thyroid Suite, which includes the See-Mode Augmented Reporting Tool, Thyroid (SMART-T), for intelligent clinical decision support and reporting automation.
2025-11
PMC (PubMed Central)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - PMC
This peer-reviewed article discusses machine learning-enabled medical devices authorized by the FDA in 2024, listing See-Mode Augmented Reporting Tool, Thyroid (SMART-T) with its K240697 510(k) clearance for thyroid ultrasound characterization.
2025-12
DeepHealth
AI assistant improves interpretation efficiency, consistency, and accuracy for thyroid ultrasound
A poster presentation at ECR 2026 highlighted how DeepHealth Thyroid AI, manufactured as See-Mode Augmented Reporting Tool, Thyroid (SMART-T), significantly reduced interpretation time and increased inter-radiologist agreement for thyroid ultrasound.
2026-02
International Journal of Innovative Technologies in Social Science
artificial intelligence for ultrasoundu2010based diagnosis and risk stratification of thyroid nodules - International Journal of Innovative Technologies in Social Science
This journal article discusses the evolution and impact of AI for thyroid ultrasound, mentioning See-Mode Augmented Reporting Tool, Thyroid (SMART-T) and its 510(k) summary from the U.S. Food and Drug Administration.
2026-05
FDA
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle database lists See-Mode Augmented Reporting Tool, Thyroid (SMART-T) with the K240697 premarket notification number, classifying it as a radiological computer-assisted detection and diagnostic software.
2026-07

Videos

Product demos, reviews, and walkthroughs for See-Mode Augmented Reporting Tool.

View all on YouTube

Frequently Asked Questions

See-Mode integrates by automatically analyzing ultrasound images to detect and characterize nodules or lesions, generating a complete sonographer worksheet and pre-populating radiologist report templates with findings and preliminary impressions. This streamlines the reporting process, reducing reporting time and enhancing consistency, and the finalized reports can be sent to PACS or RIS.
See-Mode's thyroid ultrasound analysis and reporting software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The company also holds regulatory approvals in Canada, Australia, New Zealand, and Singapore for its AI-enhanced breast and thyroid ultrasound solutions.
The See-Mode Augmented Reporting Tool is designed to assist trained medical professionals in analyzing ultrasound images and is not intended as an independent source of medical advice or to determine a course of treatment. Patient management decisions should not be made solely based on its analysis, and clinicians are expected to review and amend the AI outputs.
Studies indicate that See-Mode can improve radiologists' diagnostic performance in assessing nodule malignancy and characterizing thyroid nodules, and it has shown to outperform average reader performance for BI-RADS feature characteristics in breast ultrasounds. However, radiologists should still integrate clinical history and multi-modality imaging for final decisions, as the tool is not a standalone triage mechanism.
Several alternatives exist in the market, including other AI solutions for ultrasound such as Koios Medical, which is a competitor in thyroid and breast solutions, and general radiology reporting software like Imorgon and Rad AI. Various PACS/RIS solutions also offer structured reporting and AI integration for different ultrasound applications.
Direct pricing for the See-Mode Augmented Reporting Tool is not publicly disclosed, and interested parties typically need to contact the vendor for a quote. Similar medical imaging AI solutions often involve subscription models or may be part of larger acquisition or partnership agreements.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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