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

    PRISM ACQUIRE PRISM PROCESS PRISM VIEW

    K Number: K122026 · Decision Sep 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    2
    Review Days
    72

    Basic Information

    Device Name
    PRISM ACQUIRE PRISM PROCESS PRISM VIEW
    K Number
    K122026
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PRISM CLINICAL IMAGING, INC.
    Date Received
    July 11, 2012
    Decision Date
    September 21, 2012
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by PRISM CLINICAL IMAGING, INC.

    K Number Device Name
    K082964 PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)