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510(k) Data Aggregation

    K Number
    K180911
    Device Name
    Visura Technologies TEECAD System
    Date Cleared
    2018-06-20

    (75 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Visura Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TEECAD System is intended to provide visualization during the placement of a Transesophageal Echocardiogram (TEE) probe in adults. Do not use this system for any purpose other than the intended use.
    Device Description
    The Visura TEE Camera Assist Device (TEECAD) is an accessory that provides visualization for the physician during TEE probe placement. It consists of a very simple design that has two main components: - Disposable Carrier a single-use carrier with an integrated camera . - Viewing System a physician interface display unit . The TEECAD System is not a diagnostic or therapeutic device. The TEECAD Disposable Carrier acts as an accessory that attaches to the commercially available Philips X7-2t TEE transducer probe and is removed once the probe reaches its target location in the patient's esophagus to allow for normal ultrasound imaging of the heart. The TEECAD Disposable Carrier is a single use device, and is designed to be manufactured with commonly used medical device materials that are considered safe for body contact. The Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement. The software is installed by the manufacturer and cannot be accessed, modified or installed by the user.
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