BEUDAMED
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    Intelerad Medical Systems Incorporated

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    INTELERAD MEDICAL SYSTEMS INCORPORATED

    FDA registration
    INTELERAD MEDICAL SYSTEMS INCORPORATED·1 product·🇨🇦 Canada

    IntelePACS

    Device
    EU MDD · Eu Md Class 2a ·Intelerad Medical Systems Incorporated·On the market·1 country

    IntelePACS

    Device
    EU MDR · Eu Md Class 2a ·Intelerad Medical Systems Incorporated·On the market·1 country

    IntelePACS

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Intelerad Medical Systems Incorporated·1 device

    IntelePACS

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Intelerad Medical Systems Incorporated·1 device

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·November 30, 2017

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·July 30, 2015

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·March 7, 2014

    INTELEPACS (INTELEVIEWER)

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·February 19, 2016

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·August 5, 2016

    INTELEPACS (INTELEVIEWER)

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·September 28, 2017

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS INCORPORATED·Product code LLZ·May 1, 2015

    INTELEPACS

    FDA Adverse Event
    Malfunction ·INTELERAD MEDICAL SYSTEMS·Product code LLZ·October 27, 2008

    CE612569

    Certificate
    MDD Annex II (excluding section 4)·Intelerad Medical Systems Incorporated·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    IntelePACS - InteleConnect / TechPortal

    FDA Enforcement
    Class II ·Ongoing·INTELERAD MEDICAL SYSTEMS INCORPORATED·December 3, 2025

    IntelePACS (Image Fusion Module) - InteleViewer

    FDA Enforcement
    Class II ·Ongoing·INTELERAD MEDICAL SYSTEMS INCORPORATED·March 5, 2025

    IntelePACS (Image Fusion Module) - InteleViewer

    FDA Recall
    Open, Classified ·INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada·Product code LLZ·February 5, 2025

    IntelePACS - InteleConnect / TechPortal

    FDA Recall
    Open, Classified ·INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada·Product code LLZ·October 17, 2025

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices