BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KaVo NOMAD Pro 2 Handheld X-ray System

    K Number: K173319 · Decision Nov 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    27

    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
    KaVo NOMAD Pro 2 Handheld X-ray System
    K Number
    K173319
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aribex
    Date Received
    October 20, 2017
    Decision Date
    November 16, 2017
    Product Code
    EHD
    Advisory Committee
    Dental
    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
    EHD Unit, X-Ray, Extraoral With Timer

    Similar 510(k) Clearances

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

    Portable Dental X-ray System Model PDX nova

    FDA 510(k)
    FDA Class 2 ·Dental

    NOMAD Pro 3

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental X-RAY Unit (AJX200)

    FDA 510(k)
    FDA Class 2 ·Dental

    Portable Dental X-ray Device (GT-1)

    FDA 510(k)
    FDA Class 2 ·Dental

    Diagnostic X-Ray Equipment Model POCT22

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

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