BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    ANT-X System

    K Number: K230185 · Decision Jun 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    1
    Review Days
    129

    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
    ANT-X System
    K Number
    K230185
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ndr Medical Technology Pte. , Ltd.
    Date Received
    January 23, 2023
    Decision Date
    June 1, 2023
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

    Similar 510(k) Clearances

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

    C-beam

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intelligent NR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS genio floor; ARTIS icono.explore floor

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELLIGER ACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Trinias

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