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    K Number
    K230916
    Device Name
    WeSensor
    Manufacturer
    PICOPACK Inc.
    Date Cleared
    2023-10-10

    (190 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PICOPACK Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
    Device Description
    The WeSensor is an intraoral digital x-ray sensor. It comprises three components: (1) an intraoral digital X-ray sensor which connects to a PC via a USB port; (2) WeSensor Software package; and (3) a sensor holder as an accessory.
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