ARTAssistant

K250780

Manteia Technologies Co., Ltd. · cleared 2025-12-05 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“ARTAssistant, is a standalone software which is positioned as an adaptive radiotherapy auxiliary system, aiming to provide a complete solution to assist the implementation of adaptive radiotherapy, helping hospitals to implement adaptive radiotherapy on ordinary image-guided accelerators based on the current situation.”

AlgorithmDeep learning

source quote (p.8)

“Deep learning”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=247 images · 4 site(s)

endpoints: Normalized Mutual Information (NMI); Hausdorff Distance (HD); Gamma Pass Rate; Dice similarity coefficient

standards: AAPM TG-119

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).