OMB Individually Reported

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

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Description

The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 are indicated for the visualization of structures and dynamic processes within 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 (thyroid, breast and 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: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler , Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training. In addition to the aforementioned indications for use, when the Endoscopic Ultrasound (EUS) transducer GF-UCT180 is connected, Aplio i800 Model TUS-AI800/E3 provides image information for the diagnosis of the upper gastrointestinal tract and surrounding organs.

Detailed example

Generates automated measurements of imaged structures.

AI / analytics pattern

Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Accelerate ultrasound workflows.

Controls / human review

ATO: Not reported; PIA: Not published