See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
K240697See-Mode Technologies Pte. Ltd. · cleared 2024-09-09 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone reporting software to assist trained medical professionals in analyzing thyroid ultrasound images of adult (>=22 years old) patients who have been referred for an ultrasound examination.”
source quote (p.6)
“The software analyzes thyroid ultrasound images and uses machine learning algorithms to extract specific information.”
Validation studies (2)
Standalone
n=600 cases
endpoints: localisation; TI-RADS descriptors; FNA outcomes
standards: IEC 62304:2006/AC: 2015, ISO 14971:2019
Reader study (MRMC)
n=600 cases
endpoints: localization; characterisation of thyroid nodules
standards: IEC 62304:2006/AC: 2015, ISO 14971:2019
Reported performance (7 observations)
source quote (p.16)
“0.703 (0.642, 0.762)”
source quote (p.17)
“95.1%”
source quote (p.17)
“86.7%”
source quote (p.17)
“68.2%”
source quote (p.17)
“93.4%”
source quote (p.17)
“58.4%”
source quote (p.17)
“70.3%”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).