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

    InkSpace Imaging Body Array

    K Number: K223487 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    5
    Review Days
    17

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    Basic Information

    Device Name
    InkSpace Imaging Body Array
    K Number
    K223487
    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
    November 21, 2022
    Decision Date
    December 8, 2022
    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
    K233444 InkSpace Imaging Small Body Array
    K213397 InkSpace Imaging Pediatric Body Array