Identifiers
- 510(k) Number
- K240697 FDA 510(k)
- FDA Product Code
- QDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SMART-T Thyroid is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to analyze thyroid ultrasound images. It automates the detection, sizing, and characterization of thyroid nodules, generating a TI-RADS sonographer worksheet and preliminary radiologist impressions to streamline reporting workflows.
This software is intended for use in radiology settings and operates as a digital tool integrated into ultrasound imaging systems. It is supplied as a software application, not a physical device, and requires compatibility with existing ultrasound equipment. The system is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance (K240697) as substantially equivalent to predicate devices. No sterility or single-use requirements apply, as it is a reusable software solution.
Frequently asked questions
What types of ultrasound systems is the SMART-T Thyroid software designed to work with?
The SMART-T Thyroid is a software application intended for integration with existing ultrasound imaging systems. While the exact compatible models aren’t listed, it is designed to function as a digital tool within radiology workflows, meaning it should be compatible with systems that support radiological computer-assisted detection/diagnosis software. Compatibility details would typically be confirmed by See-Mode Technologies during implementation or purchase.
How does the SMART-T Thyroid software improve the reporting workflow for radiologists?
The SMART-T Thyroid automates key tasks in thyroid ultrasound reporting by detecting, sizing, and characterizing thyroid nodules. It generates a TI-RADS sonographer worksheet and provides preliminary radiologist impressions, which helps streamline the workflow by reducing manual effort and standardizing the initial assessment before final review.
Is the SMART-T Thyroid software reusable or single-use, and what are its storage requirements?
The SMART-T Thyroid is a reusable software solution—it does not have sterility requirements or a single-use limitation. Since it operates digitally, storage is handled via the compatible ultrasound system’s infrastructure, though proper IT maintenance and system updates are necessary to ensure continued functionality.
What regulatory pathway was followed for FDA clearance of the SMART-T Thyroid?
The SMART-T Thyroid received FDA 510(k) clearance under the traditional review pathway, classified as a Class II medical device. It was determined to be substantially equivalent to predicate devices, as indicated by the clearance type and decision code (SESE). The submission was reviewed by the Radiology (RA) Advisory Committee.
Are there multiple versions or models of the SMART-T Thyroid software, or is it a single unified tool?
The SMART-T Thyroid appears to be a single software application, though the registration numbers listed suggest it may be associated with multiple related software versions or configurations (e.g., for different ultrasound system integrations). For precise model or version details, See-Mode Technologies would provide clarification based on the specific deployment requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: See-Mode | AI-enhanced ultrasound reporting, See-Mode | Thyroid Ultrasound Reporting, See-Mode Augmented Reporting Tool, Thyroid (SMART-T) (K240697) — FDA ..., See-Mode Augmented Reporting Tool Review: Pricing, FDA Status ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240697 | Class II | Active |
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Manufacturer
- Manufacturer
- See-Mode Technologies Pte, Ltd.
Sources (1)
- FDA 510(k) K240697 24 fields · synced Sep 19, 2026