Alzevita
K252670TOPIA MEDTECH LIMITED · cleared 2025-12-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“Alzevita is a cloud-based, AI-powered medical image processing software as a medical device intended to assist neurologists and radiologists with expertise in the analysis of 3D brain MRI scans.”
AlgorithmDeep Learning based 3D U-Net++ model
source quote (p.8)
“Alzevita is a deep learning algorithm-based device. This algorithm is developed by training the Deep Learning based 3D U-Net++ model with the help of the training data.”
Adaptive (vs locked)No
source quote (p.6)
“The underlying algorithm used in Alzevita is locked, meaning it does not modify its behavior at runtime or adapt to new inputs.”
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Retrospective clinical
n=298 patients
endpoints: Dice coefficient; Hausdorff distance; Correlation Coefficient; Relative Volume Difference; Bland-Altman Mean Difference
Reported performance (1 observation)
diceas written: “Dice”0.86CI 0.85, 0.86
source quote (p.11)
“The average dice coefficient and Hausdorff distance is found to be 0.86 and 1.51 mm respectively. The following table shows the 95% confidence interval for both.”
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).