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510(k) Data Aggregation
K Number
K192253Device Name
SonicEye Dual-Array Ultrasound System
Manufacturer
Date Cleared
2020-02-25
(189 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Sonivate Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric, Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural.
The device is intended for use by medical professionals to include doctors, imaging technicians, emergency medicine and military corpsmen/medics that have been trained in basic sonography techniques. The use would include medical environments such as hospitals, clinics, military field aid stations.
Device Description
The SonicEye® Dual-Array Ultrasound System is a lightweight, battery-powered unit that contains an innovative dual-array fingertip transducer which incorporates two transducer arrays, a high-frequency linear and a low-frequency phased, in a single easily-controlled fingertip design that can be worn on the fingertip or held between the thumb and forefinger like most ultrasound probes.
The transducer is hard-wired to an image processor module that is firmware controlled. The image processor controls the behavior of the device including; beamforming, image construction, and power management; and transmits acquired data via USB cable to a computer tablet, with proprietary SonicEye Application software installed. The Windows application allow the operator to view scanned images and to control the user-selectable features of the device.
The system operates in B-Mode ONLY.
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