Cleared Traditional

K250328 - UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250328 · Canon Medical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
84d
Days
Class 2
Risk

K250328 is an FDA 510(k) clearance for the UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on April 30, 2025 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Canon Medical Systems Corporation devices

Submission Details

510(k) Number K250328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2025
Decision Date April 30, 2025
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Canon Medical Systems USA, Inc.
Yoshiaki Cook

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 285
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K250328.
Synapse 3D Base Tools (V7.2)
K254189 · Fujifilm Corporation · Apr 2026
syngo Application Software
K254184 · Siemens Medical Solutions USA, Inc. · Apr 2026
DS Core CBCT Anatomy
K260785 · Dentsply Sirona · Apr 2026
uOmnispace.MR
K253077 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2026
Folliscan
K252332 · Mim Fertility · Apr 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · Ge Medical Systems, LLC · Apr 2026