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510(k) Data Aggregation

    K Number
    K063392
    Device Name
    IMCO-STAT
    Manufacturer
    Date Cleared
    2006-12-12

    (33 days)

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

    IMCO TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IMCO-STATTM is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STATTM server in DICOM 3.0 Part 10 and JPEG format. IMCO-STAT™ is designed to send reports. images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware. 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
    IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3 0 Part 10 and JPEG format. IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware. The images may be embedded for reference in a DICOM image comprised report data, for distribution across a network and storage in a Picture Archive Communication System (PACS) with the original exam series data. Wavelet files can also be created and stored utilizing the same process. The algorithms used to create JPEG and wavelet images follow known and accepted protocols. IMCO-STAT™ uses standard off-the-shelf hardware and commercially available IMOO-07/11-1650 and operating systems. The software communicates using computer plationne and operthe network used to support the TCP/IP stack is superfluous to IMCO-STAT™
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