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    Tomtec Imaging Systems GmbH

    Manufacturer
    🇩🇪 Germany

    TOMTEC Imaging Systems GMBH

    FDA registration
    TOMTEC Imaging Systems GMBH·3 products·🇩🇪 Germany

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440211·TOMTEC-ARENA software is a clinical software pa...

    IMAGE-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440150·The IMAGE-ARENA software platform is intended t...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440204·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440143·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440198·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440167·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440181·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA

    FDA UDI
    TOMTEC Imaging Systems GmbH·04260361440174·TOMTEC-ARENA software is a clinical software pa...

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·April 1, 2020

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·August 24, 2018

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·August 16, 2018

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·September 19, 2019

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·September 19, 2019

    TOMTEC-ARENA TTA2

    FDA Adverse Event
    Malfunction ·TOMTEC IMAGING SYSTEMS GMBH·Product code LLZ·November 15, 2019

    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

    FDA Enforcement
    Class II ·Ongoing·Tomtec Imaging Systems Gmbh·July 15, 2020

    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

    FDA Recall
    Open, Classified ·Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany·Product code LLZ·September 23, 2019

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices