BEUDAMED
    Product Code: IZQ FDA class 2 21 CFR 870.1650

    Injector, Contrast Medium, Automatic

    Cardiovascular

    An automatic contrast medium injector is a powered device used in cardiovascular and other imaging procedures to deliver a precise volume and flow rate of iodinated or other contrast agents directly into vessels or body cavities, enabling consistent enhancement during angiographic studies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is IZQ, regulated under 21 CFR 870.1650, within the Cardiovascular medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    22
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    13
    Years Active
    49

    Basic Information

    Product Code
    IZQ
    Device Class
    FDA class 2
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 22 510(k) clearances via K numbers.

    K Number Device Name
    K252281 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K251295 ulrichINJECT CT Motion (XD 8000)
    K252689 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
    K241849 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
    K241850 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
    K210541 ulrichINJECT CT motion
    K192872 ulrichINJECT CT Motion
    K171392 ulrichINJECT CT motion
    K151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
    K152361 OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
    K091734 SONIC SHOT GX
    K063503 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
    K062449 EMPOWERMR INJECTOR SYSTEM, MODEL 9730
    K063090 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
    K062265 CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
    K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
    K983314 PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
    K984058 ACIST INJECTOR SYSTEM, MODEL CL100 H
    K951005 KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
    K760643 MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N
    K760641 MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.