BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Wireless/ Wired X-Ray Flat Panel Detectors

    K Number: K243734 · Decision Apr 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    8
    Review Days
    135

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    Basic Information

    Device Name
    Wireless/ Wired X-Ray Flat Panel Detectors
    K Number
    K243734
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allengers Medical Systems Limited
    Date Received
    December 4, 2024
    Decision Date
    April 18, 2025
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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