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510(k) Data Aggregation

    K Number
    K992896
    Device Name
    DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
    Date Cleared
    1999-09-03

    (7 days)

    Product Code
    Regulation Number
    892.1900
    Why did this record match?
    Product Code :

    EGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
    Device Description
    Dental automatic radiographic film processor
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    K Number
    K955825
    Device Name
    SMITH S-100 TIME & TEMPERATURE CONTROL
    Date Cleared
    1996-04-05

    (101 days)

    Product Code
    Regulation Number
    892.1900
    Why did this record match?
    Product Code :

    EGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955643
    Device Name
    ALARA IMAGING SYSTEM
    Manufacturer
    Date Cleared
    1996-03-01

    (80 days)

    Product Code
    Regulation Number
    892.1900
    Why did this record match?
    Product Code :

    EGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.
    Device Description
    The ALARA Imaging System is digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral dental images. ALARA Imaging System is comprised of the following main components: - Reusable phosphor storage screens (Denta-screens) with commercially available disposable storage screen covers; - . The ALARA Scanner, an image reader/digitizer (laser scanner and optical reader); - The ALARA Scanner/Workstation Communications Interface; - The ALARA Imaging System Workstation, with a CRT monitor, a workstation computer (the image processor), a keyboard and mouse (operator interface), proprietary workstation software, a floppy drive, and an optical hard drive (or digital analog tape) that is either resident in or attached to the workstation computer (image storage devices); - A compatible commercially available laser printer (hard copy device); . - A commercially available light box used to "erase" the phosphor storage screen "eraser"; and - . Any compatible commercially available mass storage device(s) as backup electronic archive device(s).
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