Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 is a mobile diagnostic ultrasound system for visualizing body structures and dynamic processes across multiple clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. It operates in multiple imaging modes including B-mode, M-mode, Doppler, elastography, and acoustic attenuation mapping, suitable for use by physicians and qualified personnel in hospital and clinical settings.

The subject device introduces three new transducers: EUS probe BF-UC190F (Olympus), laparoscopic/abdominal probe PET-835LA, and transesophageal cardiac probe PEI-514VX. Software improvements include cardiac 4D workflow enhancements, increased Stress Echo data storage, 3D Differential THI migration, 4D MPR image quality improvements, breast BI-RADS workflow enhancements, Shear Wave and Attenuation Imaging improvements, and DICOM RTSTRUCT format support. Fundamental imaging technology, frequency ranges (2-33 MHz), and clinical intended use remain identical to the predicate.

ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-1-2 (2020); IEC 60601-2-37 (2015); IEC 62304 (2015); IEC 62359 (2017); ISO 10993-1 (2018); ISO 13485; International Electrotechnical Commission (IEC) standards for medical devices; UL systems standards.

The subject device employs the same fundamental scientific technology as the predicate (V8.1, K233195), maintains identical clinical intended use and imaging modes, and the new transducers enable pre-existing clinical applications with no new safety concerns. The software improvements are enhancements to existing functionality (workflow, image quality, data storage) rather than new technological features. Testing per established standards demonstrates the devices meet specifications and perform as intended, with differences that do not raise new safety or effectiveness questions.