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    Konica Minolta Healthcare Americas, Inc

    FDA registration
    Konica Minolta Healthcare Americas, Inc·3 products·🇺🇸 United States

    AU 4000 U-ARM

    FDA Adverse Event
    Injury ·KONICA MINOLTA HEALTHCARE AMERICAS, INC.·Product code KPR·October 1, 2018

    SU-4000U-ARM

    FDA Adverse Event
    Malfunction ·KONICA MINOLTA HEALTHCARE AMERICAS INC.·Product code KPR·November 2, 2018

    CS-7

    FDA Adverse Event
    Malfunction ·KONICA MINOLTA HEALTHCARE AMERICAS, INC.·Product code MQB·May 2, 2018

    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC

    FDA Recall
    Terminated ·Konica Minolta Healthcare Americas, Inc.·Product code LLZ·December 3, 2021

    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

    FDA Recall
    Terminated ·Konica Minolta Healthcare, Americas, Inc.·Product code IXY·November 8, 2018

    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

    FDA Enforcement
    Class II ·Terminated·Konica Minolta Healthcare, Americas, Inc.·December 26, 2018

    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC

    FDA Enforcement
    Class II ·Terminated·Konica Minolta Healthcare Americas, Inc.·January 26, 2022