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510(k) Data Aggregation

    K Number
    K141556
    Device Name
    AVREO INTERWORKS SYSTEM
    Manufacturer
    Date Cleared
    2014-07-02

    (20 days)

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

    AVREO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.
    Device Description
    InterWorks™ is comprised of software modules that can work together to deliver an integrated solution that provides image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. The Image Management module that manages your imaging needs for a Radiology Enterprise. All of the different facets are unified under a single system that acquires, distributes, storages, displays and prints medical images. By interVIEW supporting DICOM 3.0 it can Plug-n-Play with other DICOM 3.0 compliant devices with minimal effort. For Practices that are in need of only Tele-Radiology functionality interVIEW TR will meet all the needs. The Dictation/Transcription module that provides for reliable creation of Radiology reports for your Radiology Enterprise. Reports are created via Voice Recognition with interSCRIBE VR or Digital Dictation with interSCRIBE DD depending upon the individual preferences of the Radiologist and requirements of the Radiology Enterprise. In either case digital files are created by the Radiologist and sent to transcription worklists for transcribing or editing by transcriptionists using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians. The Radiology Information System module manages your radiology workflow for your Front Desk, Back Office and Clinical operations. All of the different areas of operations are unified under a single system that extends beyond the physical walls to exchange information and perform transactions with important business partners. Most importantly, the rules engine that drives interFLOW can be tailored.
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    K Number
    K070755
    Device Name
    INTERWORKS
    Manufacturer
    Date Cleared
    2007-05-08

    (50 days)

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

    AVREO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InterWorks™ product is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.
    Device Description
    Inter Works™ is comprised of software modules that can work together to deliver an integrated solution that provides image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. The Image Management module that manages your imaging needs for a Radiology Enterprise. All of the different facets are unified under a single system that acquires, storages, displays and prints medical images. By interVIEW supporting DICOM 3.0 it can Plug-n-Play with other DICOM 3.0 compliant devices with minimal effort. For Practices that are in need of only Tele-Radiology functionality interVIEW TR will meet all the needs. The Dictation/Transcription module that provides for reliable creation of Radiology reports for your Radiology Enterprise. Reports are created via Voice Recognition with interSCRIBE VR or Digital Dictation with interSCRIBE DD depending upon the individual preferences of the Radiologist and requirements of the Radiology Enterprise. In either case digital files are created by the Radiologist and sent to transcription worklists for transcribing or editing by transcriptionists using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians. The Radiology Information System module manages your radiology workflow for your Front Desk, Back Office and Clinical operations. All of the different areas of operations are unified under a single system that extends beyond the physical walls to exchange information and perform transactions with important business partners. Most importantly, the rules engine that drives interFLOW can be tailored.
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