BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

    K Number: K241849 · Decision Nov 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    131

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    Basic Information

    Device Name
    MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
    K Number
    K241849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imaxeon Pty, Ltd.
    Date Received
    June 27, 2024
    Decision Date
    November 5, 2024
    Product Code
    IZQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZQ Injector, Contrast Medium, Automatic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IZQ), ordered by most recent decision date.

    ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ulrichINJECT CT Motion (XD 8000)

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    FDA Class 2 ·Cardiovascular

    MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

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    FDA Class 2 ·Cardiovascular

    ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ulrichINJECT CT motion

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Imaxeon Pty, Ltd.

    K Number Device Name
    K252689 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)