MEDO-Thyroid
K203502MEDO DX Pte. Ltd. · cleared 2021-04-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“MEDO-Thyroid is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of thyroid ultrasound images in adult patients of 18 years and older.”
source quote (p.5)
“MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: thyroid lobe volume measurement; nodule volume measurement; Maximum % Volume Error; ICC
standards: IEC 62304:2006/AC:2015 Medical device software – Software life cycle processes, FDA Guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”
Reported performance (2 observations)
source quote (p.7)
“0.972 (95% CI 0.969-0.975)”
source quote (p.7)
“0.973 (95% CI 0.971-0.975)”
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).