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510(k) Data Aggregation
K Number
K131973Device Name
UNEXEF-38G ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2014-11-18
(508 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
TOYOTA TSUSHO CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The system is intended for use by a qualified physician for diagnostic ultrasound imaging of the human body in Peripheral Vascular vessels.
The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.
Device Description
The UNEXEF-38G Ultrasound System is a portable, software controlled ultrasound system used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. This system is s Track 3 device that employs an ultrasound probe consisting of ultrasonic transducers arranged in a comb, whereby ultrasound can be generated by supplying electric pulse signals to a group of transducers consisting of multiple adjacent transducers in the single probe.
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