UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Canon Medical Systems CorporationThe UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.
Intended Use
UltraExtend NX CUW-U001S Ultrasound Image Analysis Program is designed to allow the user to observe images and perform analysis based on examination data acquired using diagnostic ultrasound systems TUS-AI900, TUS-AI800, and TUS-AI700. Suitable for use in hospitals and clinical settings by qualified physicians.
Technology
Software application enabling post-processing analysis of ultrasound images acquired from specific diagnostic ultrasound systems. Integrates AI/ML-enabled features such as 2D and 3D Wall Motion Tracking, Auto EF LV with Full-assist functions to aid cardiac analysis, performing these advanced analyses based on raw or image+raw data inputs.
Performance
Performance testing including risk analysis, software verification and validation, and clinical data evaluation demonstrated that the AI/ML-enabled functionalities (2D Wall Motion Tracking with Full-assist function and Auto EF with Full-assist function) perform as intended with substantial equivalence to predicate devices. Cybersecurity and quality system compliance documentation was also included.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/5/2025
2 months - 2
FDA Approval
4/30/2025
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