BEUDAMED
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    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 13, 2021

    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 20, 2016

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·May 27, 2015