UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

K250328

Canon Medical Systems Corporation · cleared 2025-04-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is designed to allow the user to observe images and perform analysis based on examination data acquired using the following diagnostic ultrasound systems; TUS-A1900, TUS-A1800, and TUS-AI700.”

AlgorithmAI/ML-enabled Full-assist function

source quote (p.7)

“2D Wall Motion Tracking, which is expanded to include left atrial analysis and the AI/ML-enabled Full-assist function for left ventricle, both of which are not available with the primary predicate device”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“Additionally, cybersecurity documentation, per the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, issued on September 27, 2023, was included in this submission.”

Validation studies (1)

Retrospective clinical

sample size not stated

standards: ISO 13485, IEC 62304, IEC 62366-1

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).