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510(k) Data Aggregation

    K Number
    K214030
    Device Name
    Universal DR 1748
    Date Cleared
    2022-01-21

    (29 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Konica Minolta Healthcare Americas, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
    Device Description
    Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.
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    K Number
    K203743
    Device Name
    EXA
    Date Cleared
    2021-12-10

    (353 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Konica Minolta Healthcare Americas, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EXA™ is a software device that receives digital images and data from various sources (i.e. CT scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.
    Device Description
    EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ PACS suite.
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