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510(k) Data Aggregation

    K Number
    K110033
    Device Name
    FEEL-DRCS
    Manufacturer
    IMFOU CO., LTD
    Date Cleared
    2011-09-15

    (253 days)

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

    IMFOU CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    feel-DRCS software, used together with digital X-ray detector is the digital X-ray image processing system designed for acquiring images and processing acquired images efficiently. The main features of this software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. feel-DRCS is compatible with DICOM 3.0 standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems. feel-DRCS is not approved for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.
    Device Description
    This medical imaging device software is composed of a combination of many functions. The functions include interfacing X-ray detector, integration X-ray generator, networking PACS, image enhancement processing and editing image/information. The name of this software is called DROC(Digital Radiography Operation Console) The operational process of feel-DRCS is described below: - 1 Input or select study information patient ID/Name, body part and projection, if you can use DICOM Modality Worklist Management SCP, you select in worklist. - Setup exposure parameter of X-ray generator (2) - After exposure, this software acquires raw images from X-ray Detector. (3) - A After acquisition of raw image, this software corrects raw image. - (5) After correction of raw image, this software processes with noise reduction, enhancement, auto windowing etc. - (6) After processing of corrected image, this software displays an image on the monitor. - (7) If this software is connected with PACS network, it transfers images to PACS Server or DICOM film printer.
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