UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
K-Number: K250328 · 2025-04-30
Device Summary
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. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K250328.
When did UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program receive FDA 510(k) clearance?
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program received FDA 510(k) clearance on 2025-04-30, under 510(k) number K250328.
Who is the listed applicant for UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program?
The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Canon Medical Systems Corporation as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.