Radiology
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Canon Medical Systems Corporation
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.
FDA Submission Metadata
- Submission number
- K250328
- Decision date
- April 2025
- FDA panel
- Radiology
- Product code
- QIH
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.