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

πŸ‡―πŸ‡΅Canon Medical Systems Corporation Β· MR image reconstruction/enhancement

What it does

Reconstructs mr images so scans acquired faster or at lower dose come out sharper and less noisy, without new hardware.

Who it's for

Imaging departments wanting shorter scans or higher throughput without buying new hardware.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics β€” we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K250328
Product codeQIH
Decision dateApr 30, 2025
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk classβ€”
Notified bodyβ€”
EMDN codeβ€”
Basic UDI-DIβ€”
AI Act classβ€”

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Founded1930-01-01 Β· via wikidata

Cite this page

RadPigeon. "UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (Canon Medical Systems Corporation)." AI Devices registry. https://radpigeon.news/ai/device/ultraextend-nx-cuw-u001s-v2-0-ultrasound-image-analysis-program

Last updated Jun 29, 2026. Information only β€” not clinical advice. Summaries are RadPigeon's own wording.