BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ExamVue Apex

    K Number: K244010 · Decision Feb 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    9
    Review Days
    60

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    Basic Information

    Device Name
    ExamVue Apex
    K Number
    K244010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jpi Healthcare Co, Ltd.
    Date Received
    December 26, 2024
    Decision Date
    February 24, 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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    Other Clearances by Jpi Healthcare Co, Ltd.

    K Number Device Name
    K260482 DRE Duo
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    K142930 Exam Vue DR
    K102327 CLEARVISION DR 7000F
    K101779 CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
    K955706 JPI AUTOMATIC X-RAY FILM PROCESSOR
    K954161 JPI INTENSIFYING SCREEN
    K950043 JPI AUTOMATIC X-RAY FILM PROCESSOR