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510(k) Data Aggregation

    K Number
    K070796
    Device Name
    CHILI PACS
    Manufacturer
    Date Cleared
    2007-04-06

    (14 days)

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

    CHILI GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e. - Displaying - Processing - Reading - Reporting - Communicating / distributing - Storing / archiving of radiological softcopy images and - Storing / archiving of structured (DICOM) reports. The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and primary diagnosis of mammography images). Therefore CHILI PACS supports the following generic imaging workflow: - Receive scheduled exams from IS at the CHILI PACS archiving component CHILI . Server - Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces - Receive and store new exams from the Modalities at the CHILI Server - · Prepare images for reading - Report new images, if required by comparing them with prior exams and reports - · Demonstrate exams at Radiological Demos - View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians). Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.
    Device Description
    CHILI PACS is a "software only" - solution. It is a modular system, consisting of modules which can be combined for the specific needs of a customer, including a backend communication and storage component and different workplace deployments for medical imaging tasks and applications. CHILI PACS is the integrated radiology suite for radiological practices and community hospitals. Important factors are the centralized server structure, the wide-ranging data distribution and the overall integrated concept, ranging from reporting and archiving as well as image and report distribution. The three CHILI PACS workplace deployments - a) CHILI Web for image distribution (web-based viewing application suited for primary diagnosis) - b) CHILI Workstation for reporting, inside as well as outside of the radiology (standalone workstation or client workstation connected to server) - c) CHILI 3D-Plugln (optional) for 3D- and 4D reconstructions of image slices generated by digital modalities and stored in the DICOM format (not intended for primary diagnosis) are medical diagnostic and viewing workstations intended for manipulating, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allows radiologists, radiological technicians and health care professionals to receive and process all data needed. Data Management: CHILI Server. Ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy. The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports. Integration: CHILI Workflow Integration. The Workflow Management enables by integration of any HL7- / DICOM-compatible HIS, RIS (IHE Year 5) and other information systems to the CHILI PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.
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