BEUDAMED
    2 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·April 11, 2018

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013