FDA 510(k)

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

K-Number: K250328 · 2025-04-30

ApplicantCanon Medical Systems Corporation

Decision Date2025-04-30

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-04-30 under approval number K250328. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program?

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K250328.

When was UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program approved by the FDA?

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program received FDA 510(k) clearance on 2025-04-30, under approval number K250328.

What company makes UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program?

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program?

The FDA product code for UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is QIH.

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Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40444060 Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union. Frontiers in medical technology (2025) PMID: 33890129 [Diagnostics of diseases of the optic nerve head in times of artificial intelligence and big data]. Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft (2021) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.