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

    Rover

    K Number: K201488 · Decision Jul 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    43

    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
    Rover
    K Number
    K201488
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-X , Ltd.
    Date Received
    June 4, 2020
    Decision Date
    July 17, 2020
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

    Similar 510(k) Clearances

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

    Portable DR Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAYMO Mobile X-ray System (Model: RAYMO)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Airbile-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mobile X-ray unit (!M1)

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