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510(k) Data Aggregation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Speaker Dock:
    The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

    VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Speaker Dock:
    The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

    • Intraoperative (Microvascular and Vascular)
    • Intraoperative Neurological
    • Transrectal and Peripheral Vascular.
    Device Description

    VascuChek® Surgical is a cardiovascular blood flowmeter comprised of three components: a sterile VascuChek® Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek® Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. The VascuChek® Transceiver is Bluetooth enabled and connects to the VascuChek® Speaker Dock.

    VascuChek® Clinical is a cardiovascular blood flowmeter comprised of three components: a non-sterile VascuChek® Clinical Probe which connects to the reusable, nonsterile VascuChek® Transceiver. The VascuChek® Transceiver is Bluetooth enabled and connects to the VascuChek® Speaker Dock.

    The VascuChek® device follows Track 1.

    A transmitter in the VascuChek® Transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker.

    AI/ML Overview

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