BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PathVisionXL

    K Number: K183142 · Decision Mar 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    PathVisionXL
    K Number
    K183142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Faxitron Bioptics, LLC
    Date Received
    November 13, 2018
    Decision Date
    March 14, 2019
    Product Code
    MWP
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWP Cabinet, X-Ray System

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    Other Clearances by Faxitron Bioptics, LLC

    K Number Device Name
    K173309 Faxitron VisionCT
    K170786 Faxitron Bioptics Speciemen Radiography System
    K153583 BioVision Plus
    K122428 FAXITRON SPECIEN RADIOGRAPHY SYSTEM