BEUDAMED
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    SCOPIX

    FDA registration
    SCOPIX·1 product·🇮🇱 Israel

    SCOPIX VIDEO IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCOPIX LASER IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LMC·November 25, 2003

    Scopis ENT

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327413199·Scopis ENT Software with Target Guided Surgery

    Scopis ENT

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327413243·Scopis ENT Software

    Scopi-pants

    Device
    EU MDR · Eu Md Class 1 ·Ningbo Transo-Medical Co., Ltd.·On the market

    E-SCOPICS

    Manufacturer
    🇫🇷 France·1 Basic UDI-DI·2 Devices

    Scopio Labs Ltd.

    Manufacturer
    🇮🇱 Israel·1 Importer

    E-SCOPICS

    FDA registration
    E-SCOPICS·3 products·🇫🇷 France

    Scopis

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327513943·ENT Software

    Scopis

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327514179·ENT Software with TGS

    Scopis

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327513950·Planning Software

    SCOPIO LABS LTD.

    FDA registration
    SCOPIO LABS LTD.·1 product·🇮🇱 Israel

    Hepatoscope

    Device
    EU MDR · Eu Md Class 2a ·E-SCOPICS·On the market·1 country

    Hepatoscope

    Device
    EU MDR · Eu Md Class 2a ·E-SCOPICS·On the market·1 country

    8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code PGW·April 4, 2024

    Hepatoscope

    FDA UDI
    E-SCOPICS·03770023859011·The device is intended for general purpose puls...

    Hepatoscope

    FDA UDI
    E-SCOPICS·03770023859004·The device is intended for general purpose puls...

    Hybrid Navigation Unit EM

    FDA UDI
    Scopis GmbH·B057U2040040·The Hybrid Navigation Unit EM is a high perform...