BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Yushan X-Ray Flat Panel Detector

    K Number: K243171 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    80

    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
    Yushan X-Ray Flat Panel Detector
    K Number
    K243171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innocare Optoelectronics Corp.
    Date Received
    September 30, 2024
    Decision Date
    December 19, 2024
    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

    Other Clearances by Innocare Optoelectronics Corp.

    K Number Device Name
    K250211 Yushan X-Ray Flat Panel Detector
    K220510 Yushan X-Ray Flat Panel Detector with DROC
    K210988 Yushan X-Ray Flat Panel Detector with DROC
    K201528 Yushan X-Ray Flat Panel Detector with DROC
    K191939 Yushan X-Ray Flat Panel Detector