BEUDAMED
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    Philips Healthcare Informatics, Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·DEKRA Certification B.V.

    IntelliSpace Clinical Applications

    Device
    EU MDD · Eu Md Class 2a ·Philips Healthcare Informatics, Inc.·On the market·9 countries

    IntelliSpace Radiology

    Device
    EU MDD · Eu Md Class 2a ·Philips Healthcare Informatics, Inc.·On the market·9 countries

    IntelliSpace Clinical Applications

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838091849·Philips IntelliSpace Clinical Applications is a...

    IntelliSpace PACS

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838074781·IntelliSpace PACS is an image management system...

    IntelliSpace Radiology

    FDA UDI
    Philips Healthcare Informatics, Inc.·00884838091740·IntelliSpace Radiology Software (client) is a s...

    IntelliSpace Clinical Applications_US

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Philips Healthcare Informatics, Inc.·1 device

    IntelliSpace Radiology

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Philips Healthcare Informatics, Inc.·1 device

    iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code LLZ·August 29, 2008

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·February 13, 2009

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·February 1, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·March 11, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·May 17, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·April 26, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·April 26, 2010

    ISITE PACS

    FDA Adverse Event
    Other ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·December 2, 2009

    ISITE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·August 3, 2011

    ISITE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·November 18, 2008

    ISITE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE INFORMATICS, INC·Product code LLZ·September 8, 2011

    ISITE PACS

    FDA Adverse Event
    Injury ·PHILIPS HEALTHCARE INFORMATICS, INC.·Product code LLZ·July 6, 2011