Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5

“The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUSAA450 and Aplio a Model CUS-AA000 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (including thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural. This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart 3D, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training. The expansion of marketing language for several previously 510(k) cleared features is also proposed in the subject submission, including the promotion of the support by artificial intelligence (AI) and/or machine learning (ML) of the automated initial contour tracing capability of 2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF), marketed by Canon as 2D WMT with Full-assist function and Auto EF with Full-assist function, respectively.”

“The expansion of marketing language for several previously 510(k) cleared features is also proposed in the subject submission, including the promotion of the support by artificial intelligence (AI) and/or machine learning (ML) of the automated initial contour tracing capability of 2D Wall Motion Tracking for left ventricle (2D WMT) and Auto Ejection Fraction for left ventricle (Auto EF), marketed by Canon as 2D WMT with Full-assist function and Auto EF with Full-assist function, respectively.”

“Additionally, cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 18, 2018, was included in this submission.”