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

    E-SCAN MRI SYSTEM

    K Number: K012728 · Decision Aug 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    20
    Review Days
    14

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    Basic Information

    Device Name
    E-SCAN MRI SYSTEM
    K Number
    K012728
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosound Esaote, Inc.
    Date Received
    August 15, 2001
    Decision Date
    August 29, 2001
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Biosound Esaote, Inc.

    K Number Device Name
    K023255 TECHNOS MP, MODEL AU6
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    K020164 E-SCAN XQ
    K010405 7230 ULTRASOUND IMAGING SYSTEM WITH TEI
    K010057 MODIFICATION TO ARTOSCAN M
    K001894 MODIFICATION TO E-SCAN
    K000931 AU5 ULTRASOUND IMAGING SYSTEM
    K000681 AU5, AU6
    K994369 7250 (MEGAS)
    K990968 E-SCAN
    Search all 20 clearances from Biosound Esaote, Inc. →