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

The UltraExtend NX V2.0 is ultrasound image analysis software that allows physicians and trained clinical staff to observe and analyze ultrasound images in hospital and clinical settings. It processes examination data acquired from Canon's Aplio i900/i800/i700 diagnostic ultrasound systems, accepting RAW data or Image + RAW formats for post-processing and measurement.

The subject device employs the same fundamental scientific technology as the predicate device (UltraExtend FX V2.02) and provides identical software features except for expanded measurement packages (Standard, Application, Obstetrics), enhanced Cardiac4D capabilities, and new AI/ML-enabled features including 2D/3D Wall Motion Tracking, Auto EF with left ventricle full-assist, left atrial analysis, Aortic Valve Analysis, Smart Fetal Heart, Flex-M, and Vascularity Index. The AI/ML functions were integrated without modification from a reference device (Aplio i900/i800/i700 K223017).

IEC 62304 Edition 1.1 (2015-06) medical device software lifecycle processes; IEC 62366-1 Edition 1.1 (2020-06) usability; ISO 13485 quality management; 21 CFR 820 Quality System Regulations. Software documentation followed FDA guidance on device software functions (June 14, 2023) and cybersecurity considerations (September 27, 2023).

The subject device is substantially equivalent because it has identical clinical intended use (post-processing of ultrasound data), the same fundamental technology, and identical core functionality to the predicate, with differences only in expanded features and AI/ML capabilities. Performance testing using representative clinical datasets and the same acceptance criteria as the reference device demonstrated these expanded features perform as intended with substantial equivalence. The integration of pre-cleared AI/ML functions without modification, combined with identical basic functionality and intended use, establishes substantial equivalence despite the expanded feature set.