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510(k) Data Aggregation
K Number
K223347Device Name
UltraSight AI Guidance
Manufacturer
UltraSight Inc.
Date Cleared
2023-07-24
(265 days)
Product Code
QJU
Regulation Number
892.2100Why did this record match?
Applicant Name (Manufacturer) :
UltraSight Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraSight AI Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Al Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Al Guidance is indicated for use in two-dimensional transthoracic echocardiography (2D- TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
Device Description
UltraSight Al Guidance is a mobile application based on machine learning that uses artificial intelligence (AI) to provide dynamic real-time guidance on the position and orientation of the transducer to help non-expert users acquire diagnostic-quality tomographic views of the system provides guidance for ten standard cardiac views.
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