AmCAD-UT
K203555AmCad BioMed Corporation · cleared 2021-09-08 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“AmCAD-UT is a Windows-based computer-aided detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images with the region of interest (ROI) of a selected nodule defined by users or suggested by an AI algorithm after the user specifies the location of the nodule.”
AlgorithmAI, Statistical Pattern Recognition and Quantification method
source quote (p.8)
“Based on AI, Statistical Pattern Recognition and Quantification method”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedNo
Validation studies (1)
Standalone
sample size not stated
endpoints: effectiveness in determining the contour of thyroid nodules
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
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).