BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

    K Number: K151048 · Decision Jan 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    277

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
    K Number
    K151048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bracco Injeneering
    Date Received
    April 20, 2015
    Decision Date
    January 22, 2016
    Product Code
    IZQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    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)

    FDA 510(k)
    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)

    FDA 510(k)
    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)

    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

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

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