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510(k) Data Aggregation
K Number
K100837Device Name
PACENTRIC CONNECT, TRAVELER AND WEB
Manufacturer
Date Cleared
2010-12-03
(254 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
FIMREITE SOFTWARE AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PaCentric is a software only device intended for viewing of images acquired from CT, MR, CR, US and other DICOM compliant medical imaging systems when installed on suitable commercial hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. The device is not intended for clinical viewing of mammography images.
Device Description
PaCentric Web is an Internet application for read-only review of external image deliveries. PaCentric Web facilitates the display and/or transfer of clinical DICOM images and reports to a Web browser. PaCentric is ensuring secure and time-limited access to clinical data. The receiver will only have access to the relevant data for a particular delivery. Using PaCentric, patient data can be delivered to a specific recipient anywhere in the world. PaCentric Web gives a qualified user read-only access to an image delivery. Access is given with a key and password, which must be provided by the Sender. PaCentric Web features commonly used tools and features found on DICOM workstations: Preview image icons from which the user may select images to review in full size; Measurements: Distance, Area, Volume, Angle and ratios. Measurement calibration based on information provided by the relevant DICOM tag. The measurements are performed by having the user select a caliper and marking end points by clicking with a mouse button. The results are being displayed and updated in a results area on the screen; Horizontal and Vertical invert, i.e. flipping the image sideways or upside-down; Color maps. A pixel consists of three sets of values from 0 to 255 that together constitute a color or a gray level. Technically, these RGB values are reduced according to desired color hue. A grayscale image therefore will not lose any details in the image for higher or lower values. This function is mostly used for MONOCHROME1 and MONOCHROME2 images; Window-leveling and Brightness control. These Attributes is only used for Images with Photometric Interpretation (0028,0004) values of MONOCHROME1 and MONOCHROME2. They have no meaning for other Images. When working with DICOM images, the user has the ability to make changes to the displayed images, on a global level, by manipulating the Window Level. Tonal changes to specific areas of an image. Window Center DICOM TAG 0028,1050 and Window Width DICOM TAG 0028,1051 specify a linear conversion from stored pixel values (after any Modality LUT or Rescale Slope and Intercept specified in the IOD have been applied) to values to be displayed. Window Center contains the input value that is the center of the window. Window Width contains the width of the window. Note: The terms "window center" and "window width" are not consistently used in practice, nor were they defined in previous versions of the standard. The definitions here are presented for the purpose of defining consistent meanings for identity and threshold transformations while preserving the common practice of using integral values for center and width. Zoom - Image is downloaded in its original size, but the height and width definition can be adjusted and will therefore function as zoom. Language selection. Default language is based on current location derived from the IP address of the viewer. Simple printable report with preview and selectable fields: Display of patient demographics: Sex, age, date of examination, nationality, operator, weight, referring physician, height, performing physician, body surface area (BSA), location, BP, Sender address, Description, Diagnosis, Comments, Images, selectable signature lines. Ability to display up to eight independent image areas at the same time.
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