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510(k) Data Aggregation

    K Number
    K092915
    Device Name
    CEDARA WEBACCESS, MODEL: 2.4
    Manufacturer
    CEDARA SOFTWARE CORP.
    Date Cleared
    2010-06-23

    (274 days)

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

    CEDARA SOFTWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. 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 MP resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. With no application-specific installation required on the user's computer, qualified medical professionals can use Cedara WebAccess 2.4 with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Imaging Series and file attachments. Cedara WebAccess 2.4 was designed with an easy and convenient workflow providing image viewing tools including zoom, pan, contrast, series/layout change, toggle on/off image text, MPR, CINE, reset and measurement. The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.
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    K Number
    K053301
    Device Name
    CEDARA I-RESPONSE CEDARA PET/CT
    Manufacturer
    CEDARA SOFTWARE CORP.
    Date Cleared
    2006-02-03

    (67 days)

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

    CEDARA SOFTWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipulation of multi-modality softcopy images. Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI, PET, SPECT, and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols. Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (c.g., tumors, abscesses, AVMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression.
    Device Description
    The Cedara I-Response and Cedara PET/CT software products are line extensions to Cedara's medical image processing workstation product, Cedara I-SoftView™. The products are designed to facilitate the oncology or other clinical specialty workflow by comparing medical imaging data from different modalities and/or from different time points. The products are able to coregister functional MRI, PET, SPECT, CT, or other modality datasets. segment out Regions of Interest (ROI), and calculate, display, and report relative differences in Apparent Diffusion Coefficient (ADC). Standardized Update Value (SUV), or other values within those regions. The products can be used as standalone applications or can be "plugged in" and launched from within other applications such as Cedara I-SoftView, or from another workstation or console.
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    K Number
    K040468
    Device Name
    CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
    Manufacturer
    CEDARA SOFTWARE CORP.
    Date Cleared
    2004-04-23

    (59 days)

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

    CEDARA SOFTWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images including the use of prosthetic template overlays, and including mammography. Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
    Device Description
    Cedara I-ReadMammo is medical image review workstation software that is comprised of features that are previously cleared in Cedara I-SoftView. The differences lie mainly in workflow and user interface that make mammography image viewing more convenient for the user. The product consists of features that allow the qualified medical professional to view patient medical images with the desired viewing protocol and workflow in order to optimize the efficient use of their time. Additionally, as with all Cedara I-SoftView offerings, measurements that are commonly required for diagnosis and surgical planning are available to the user.
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    K Number
    K022881
    Device Name
    CEDARA I-SOFTVIEW
    Manufacturer
    CEDARA SOFTWARE CORP.
    Date Cleared
    2002-10-22

    (53 days)

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

    CEDARA SOFTWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations – Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images. This includes the use of prosthetic template overlays Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
    Device Description
    The Cedara Orthopedic tool set is a new option available in the Cedara I-SoftView product which is a line extension of Cedara's medical image processing workstation product, "Medical Imaging Family of Workstations". The Cedara Orthopedic tool set is a software accessory that will be typically used for orthopedic applications and consists of features that allow the qualified medical professional to make measurements that are commonly required when doing orthopedic surgical planning. In addition to circle, line and angle measurements, the physician can also display electronic implant templates that can aid in implant size and positioning determination prior to surgery.
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    K Number
    K002590
    Device Name
    CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
    Manufacturer
    CEDARA SOFTWARE CORP.
    Date Cleared
    2000-10-31

    (71 days)

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

    CEDARA SOFTWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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