Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

The Aplio beyond and Aplio me Software V2.0 are mobile diagnostic ultrasound systems used to visualize structures and dynamic processes within the human body for diagnosis across multiple clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. The systems provide various imaging modes including B-mode, M-mode, Doppler modes, elastography, and acoustic attenuation mapping, and are intended for use by physicians or trained healthcare professionals in hospital and clinical settings.

The subject devices employ the same fundamental scientific technology as the predicate but differ in several ways: they use bipolar pulse transmission instead of linear pulse trains, simultaneously receive up to 128 channel signals versus 256 in the predicate, do not support 2D array transducers, lack DVI video output support, and have different monitor sizes. Some Aplio beyond features include Precision+ Fine Processing and Breast Scan Guide, while the Aplio me has more limited sensor-dependent features than the predicate device.

Testing was conducted in accordance with ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2 (2020), IEC 60601-2-37 (2015), IEC 62304 (2015), IEC 62359 (2017), and ISO 10993-1 (2018). The devices were designed under Quality System Regulations (21 CFR 820) and ISO 13485 standards. FDA guidance documents on diagnostic ultrasound systems and device software were referenced.

The Aplio beyond and Aplio me V2.0 are substantially equivalent to the Aplio i700 V8.5 predicate device because they share the same clinical intended use, imaging modes, and fundamental technological characteristics, with documented differences shown to not raise new safety or effectiveness questions. The software architecture was largely unchanged when migrated to the subject devices, and bench testing confirmed no device dependencies affect previously demonstrated software performance. Newly developed transducers employ the same fundamental scientific technology and are substantially equivalent to existing predicate transducers.