BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

    K Number: K113748 · Decision Mar 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    14
    Review Days
    93

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    Basic Information

    Device Name
    IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
    K Number
    K113748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imris, Inc.
    Date Received
    December 21, 2011
    Decision Date
    March 23, 2012
    Product Code
    HBL
    Advisory Committee
    Neurology
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by Imris, Inc.

    K Number Device Name
    K143420 SYMBIS Surgical System
    K141950 HFD100 ROCKER ARM ACCESSORY
    K133692 IMRI 1.5T AND IMRI 3T S
    K130224 ICT
    K123091 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
    K121997 IMRIS ONCOLOGY PACKAGE
    K103493 HEAD FIATION DEVICE (HFD 100)
    K103506 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
    K101813 IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
    K091166 IMRX
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