BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Wireless Digital Flat Panel Detector

    K Number: K161730 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    168

    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
    Wireless Digital Flat Panel Detector
    K Number
    K161730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iray Technology (Shanghai) , Ltd.
    Date Received
    June 23, 2016
    Decision Date
    December 8, 2016
    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)

    Similar 510(k) Clearances

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

    VIVIX-S 4386W (FXRD-4386WA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Universal 1417PI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lux HD 2530 detector (Lux HD 2530)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Yushan X-Ray Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKR 3000

    FDA 510(k)
    FDA Class 2 ·Radiology

    Wireless/ Wired X-Ray Flat Panel Detectors

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