BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    D2RS_AT Digital Dynamic Remote System

    K Number: K150306 · Decision Oct 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    1
    Review Days
    243

    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
    D2RS_AT Digital Dynamic Remote System
    K Number
    K150306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stephanix Radiological Solutions
    Date Received
    February 9, 2015
    Decision Date
    October 10, 2015
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    Similar 510(k) Clearances

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

    Nexus DRF Digital X-ray Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Insight Enhanced™ DRF (EN-1002-01)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Soteria E-View

    FDA 510(k)
    FDA Class 2 ·Radiology

    Adora DRFi (04550010)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIDENT Mobile Fluoroscopy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProxiDiagnost N90 / Precision CRF (706110, 706400)

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