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    VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

    Device
    EU MDD · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

    VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

    Device
    EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

    VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

    Device
    EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

    VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

    Device
    EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

    Vara PACS

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·MX Healthcare GmbH·1 device

    aycan PACS

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·aycan Digitalsysteme GmbH·3 devices

    CHILI PACS

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·NEXUS / CHILI GmbH·6 devices

    iQ-SYSTEM PACS

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·IMAGE Information Systems Europe GmbH·5 devices

    MERLIN Diagnostic Workcenter

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Phönix-PACS GmbH·1 device

    MERLIN Diagnostic Workcenter

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·3 devices

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    FDA Enforcement
    Class II ·Ongoing·MedicalCommunications GmbH·October 8, 2025

    3M Deutschland GmbH (Medical)

    Importer
    🇩🇪 Germany·2 Manufacturers

    Ellecom GmbH

    Authorized representative
    🇩🇪 Germany·11 Manufacturers·11 Devices

    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 6, 2014

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    Gynemed GmbH & Co. KG

    Importer
    🇩🇪 Germany·9 Manufacturers

    Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·October 30, 2019

    Llins Service & Consulting GmbH

    Authorized representative
    🇩🇪 Germany·39 Manufacturers·556 Devices