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510(k) Data Aggregation

    K Number
    K122260
    Device Name
    AYCAN MOBILE
    Manufacturer
    AYCAN DIGITALSYSTEME GMBH
    Date Cleared
    2012-09-12

    (47 days)

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

    AYCAN DIGITALSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only. aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography.
    Device Description
    aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.
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    K Number
    K103546
    Device Name
    AYCAN WORKSTATION OSIRIX PRO
    Manufacturer
    AYCAN DIGITALSYSTEME GMBH
    Date Cleared
    2011-03-17

    (105 days)

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

    AYCAN DIGITALSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    aycan workstation OsiriX PRO is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
    Device Description
    The aycan workstation OsinX PRO provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX PRO runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images. aycan workstation OsiriX PRO is a software device that handles and manipulates digital medical images.
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    K Number
    K063470
    Device Name
    AYCAN WORKSTATION OSIRIX
    Manufacturer
    AYCAN DIGITALSYSTEME GMBH
    Date Cleared
    2007-01-05

    (50 days)

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

    AYCAN DIGITALSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
    Device Description
    The aycan Workstation OsiriX provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images.
    Ask a Question

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