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510(k) Data Aggregation

    K Number
    K162285
    Device Name
    EBM iDO Viewer 1.2.1
    Date Cleared
    2017-01-27

    (165 days)

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

    EBM Technologies Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EBM iDO Viewer 1.2.1 software is intended to display images from CT. MR . CR. US. XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
    Device Description
    EBM iDO Viewer 1.2.1 is a software device that can be installed on Apple iPad Pro Through wireless network, user can login, query and display the images which are stored in heir existing EBM PACS server. The device can be installed in iOS 5.0 or later version platform such as iPad, but can't be installed in platforms other than iOS 5.0 or later version . It will be almost the same image quality of CT, MR , US, XA and SC as displayed on iPad Pro when it is used for diagnosis purpose. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro.
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    K Number
    K142514
    Device Name
    UniWeb 8.0
    Date Cleared
    2014-12-18

    (101 days)

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

    EBM Technologies Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations. UniWeb™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
    Device Description
    UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
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