Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K063188
    Device Name
    DEL-IMS
    Date Cleared
    2006-11-30

    (41 days)

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

    DEL MEDICAL IMAGING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    The DEL-IMS is intended to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital image capture device. It synchronizes the ready states of the digital image capture device and the radiographic equipment when a single x-ray console is desired, to provide the x-ray console features (e.g. technique selection) of the radiographic equipment.
    Ask a Question

    Ask a specific question about this device

    K Number
    K992037
    Device Name
    MAMEX
    Date Cleared
    1999-07-30

    (44 days)

    Product Code
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEL MEDICAL IMAGING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The option intended to provide the operator with the capabilities of selecting Rhodium filtration for enhanced image quality.
    Device Description
    Rhodium filtration option for use with "Mamex" Mammographic X- Ray system.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1