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

    Europa (Alternative: AiRTouch) portable X-ray system

    K Number: K244049 · Decision May 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    148

    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
    Europa (Alternative: AiRTouch) portable X-ray system
    K Number
    K244049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Livermoretech, Inc.
    Date Received
    December 31, 2024
    Decision Date
    May 28, 2025
    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

    Other Clearances by Livermoretech, Inc.

    K Number Device Name
    K193535 EZER, Portable X-ray System
    K200022 FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
    K193644 E-COM DR-2000 DR
    K190935 EZER, Portable X-ray System
    K180663 LaVid FMTS DIAGNOSTIC X-RAY SYSTEM