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

    IN-VISION IMAGING SYSTEM

    K Number: K031148 · Decision May 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    IN-VISION IMAGING SYSTEM
    K Number
    K031148
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jomed, Inc.
    Date Received
    April 10, 2003
    Decision Date
    May 28, 2003
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXK Echocardiograph

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    Other Clearances by Jomed, Inc.

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    K031346 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
    K031277 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
    K022762 JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
    K021219 SMARTWIRE/SMARTMAP PRESSURE SYSTEM
    K003938 TRAK BACK II