ARTAssistant

K250780

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.10)
“ARTAssistant is a software only device and will not come in contact with the patient, thus biocompatibility testing is not applicable.”
AlgorithmIntensity based (for registration), Deep learning (for image conversion)
source quote (p.8)
“Auto Rigid Registration Algorithm Intensity based, Auto Deformable Registration Algorithm Intensity based, Image Conversion Algorithm Deep learning”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

endpoints: Normalized Mutual Information (NMI); Hausdorff Distance (HD)

Bench

sample size not stated

endpoints: Normalized Mutual Information (NMI); Hausdorff Distance (HD)

Bench

n=247 images

endpoints: 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

0
recalls in product code, 24mo
0
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250780