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

    SURGIVISIO Device

    K Number: K220627 · Decision Mar 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    6
    Review Days
    14

    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
    SURGIVISIO Device
    K Number
    K220627
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ecential Robotics
    Date Received
    March 4, 2022
    Decision Date
    March 18, 2022
    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

    Other Clearances by Ecential Robotics

    K Number Device Name
    K242914 Op.n(TM) Navigation
    K233228 Spine Navigation and Robotic-Assistance Device
    K231886 SURGIVISIO Device
    K221028 SURGIVISIO Device
    K220946 SURGIVISIO Device