Introduction
The Aplio i900/1800/i700/i600, Aplio a550, Aplio a450, Aplio a, Xario2OOG, and XariolOOG Diagnostic Ultrasound Systems are indicated for the visualization of structures and dynamic processes within the human body using ultrasound, providing image information for diagnosis in various clinical applications.
Clinical Applications
The systems are intended for use in fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), and laparoscopic applications.
Regulatory Information
The devices have been determined to be substantially equivalent to legally marketed predicate devices and may be marketed subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
The devices are classified as Class II devices and are subject to the requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Manual:
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