510(k) · Radiology

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

by Canon Medical Systems Corporation

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is an AI-enabled medical device from Canon Medical Systems Corporation that the U.S. FDA cleared through 510(k) K250328 on April 30, 2025. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK250328
Pathway510(k)
Date of final decision
Company (FDA list)Canon Medical Systems Corporation
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Canon Medical Systems Corporation
Applicant locationOtawara-Shi, JP
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program went through this pathway (K250328).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #193 of 305 under that code. Canon Medical Systems Corporation has 42 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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