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

    InkSpace Imaging Small Body Array

    K Number: K233444 · Decision Jan 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    InkSpace Imaging Small Body Array
    K Number
    K233444
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inkspace Imaging, Inc.
    Date Received
    October 19, 2023
    Decision Date
    January 8, 2024
    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 Inkspace Imaging, Inc.

    K Number Device Name
    K253182 InkSpace Imaging Small Body Array (SBA12PH30x)
    K243675 InkSpace Imaging Small Body Array
    K223487 InkSpace Imaging Body Array
    K213397 InkSpace Imaging Pediatric Body Array