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510(k) Data Aggregation

    K Number
    K994329
    Device Name
    IIVS INTEGRATED IMAGE VIEWING STATION
    Manufacturer
    TERARECON, INC.
    Date Cleared
    2000-05-26

    (156 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
    Device Description
    The IiVS™ Integrated image Viewing Station is a product family, which comes in two different versions: DiVS: a DICOM viewer IiVS: a 3D viewer. The intended use of the devices is to provide solutions to various medical image-viewing problems, which come about as the modalities generate more and more images. They also support image distribution over networks, and are DICOM conformant. Finally, the IIVS™ Integrated image Viewing Station family supports the radiologist in writing a report, and transmitting and storing this report in digital form.
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    K Number
    K992698
    Device Name
    STENTOR, PAGEVIEW
    Manufacturer
    STENTOR, INC.
    Date Cleared
    1999-10-25

    (75 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
    Device Description
    Stentor PageView is a digital medical imaging distribution and display system to be used for both primary diagnosis and efficient distribution of medical images within the healthcare enterprise. It operates on the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows NT, Windows 95, and Windows 98). The system does not permanently store or produce original medical images.
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    K Number
    K992426
    Device Name
    RAYPAX WEB CLINICAL SYSTEM
    Manufacturer
    SAMSUNG SDS CO., LTD
    Date Cleared
    1999-10-13

    (84 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
    Device Description
    The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.
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    K Number
    K992352
    Device Name
    ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
    Manufacturer
    INTELERADIOLOGY, INC.
    Date Cleared
    1999-09-29

    (77 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iTR2000 is a software communications tool intended to be used in the transportation, storage and retrieval of digital medical images for the purpose of off-site review.
    Device Description
    iTR2000™ is a stand-alone software product which may be marketed as a software-only product, as well as for use in conjunction with standard PC hardware, off-the-shelf software or third-party teleradiology/PACS software. iTR2000™ provides short-term remote access to medical images by radiologists, referring physicians and other licensed professionals, utilizing a personal computer or workstation with internet access. Images are securely stored on a internet website for on-demand remote retrieval via the iTR2000™ software, or via a standard web browser without the use of propriety software. The iTR2000™ system employs the latest internet security techniques and meets all current federal medical communications standards including recent proposals from HCFA and HHS. iTR2000™ is primarily intended to allow the transmission, retrieval and review of images produced by imaging equipment otherwise not part of a digital Picture Archive and Communication System (PACS) network or legacy equipment not compatible with ACR/NEMA DICOM 3.0. Conventional film-based images can be optically digitized and stored in a standard image format, such as JPEG. iTR2000™ can also be configured to web-enable third-party DICOM-capable teleradiology/PACS systems in low-volume environments for remote or on-call activities. iTR2000™ is designed for use primarily with small-matrix imaging modalities, such as images produced by Computed Tomography (CT), Ultrasound (US), Magnetic Resonance Imaging (MRI), Nuclear Medicine (NM), digital flourography and digital angiography. The use of images produced by large-matrix imaging systems, such as digitized radiographic films and computed radiography or mammography. requires the use of digitization and viewing equipment which exceed the stated minimum requirements for the standard iTR2000™ system. iTR2000™ does not control the actual image-taking system (i.e. x-ray, MRI, ultrasound or scintography machines).
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    K Number
    K991537
    Device Name
    SAMSUNG RAYPAX SYSTEM
    Manufacturer
    SAMSUNG SDS CO., LTD
    Date Cleared
    1999-07-06

    (64 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Samsung RAYPAX™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
    Device Description
    The Samsung RAYPAX™ system handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
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    K Number
    K984000
    Device Name
    STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
    Manufacturer
    SURGICAL NAVIGATION TECHNOLOGIES, INC.
    Date Cleared
    1999-01-12

    (63 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StealthSERVER™ Image Storage and Communication System is used to store and provide remote viewing access to diagnostic images via a LAN, the internet or modem. In addition, the system can be used to remotely set surgical plans for stereotactic surgery that are compatible with and can be accessed by the StealthStation® Treatment Guidance Platform.
    Device Description
    This submission describes a network server system that provides remote access to digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.
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    K Number
    K974707
    Device Name
    IMAGEQUEST
    Manufacturer
    VISUAL MED, INC.
    Date Cleared
    1998-07-31

    (227 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.
    Device Description
    ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.
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    K Number
    K981053
    Device Name
    KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    1998-06-18

    (87 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS system for the distribution, viewing, and printing of medical images at distributed locations.
    Device Description
    The Kodak Digital Science™ (KDS) ImageVIEW family of products is designed to facilitate the distribution of images from standard DICOM storage devices within the radiology department and provide controlled Internet access to images stored on DICOM storage devices. Browser extensions will allow dynamic viewing and manipulation of these medical images. This family of products will initially provide image viewing and referral printing functionality to referring and clinical physicians, but will be extended to provide diagnostic viewing and printing functionality for radiology use. They will also provide intelligent management of images and information to facilitate productivity enhancements for its users. ImageVIEWs are not represented to be of use in supporting or sustaining human life, nor do they represent a potential of unreasonable risk of illness or injury.
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    K Number
    K980918
    Device Name
    JPACS
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Date Cleared
    1998-06-03

    (84 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JPACS radiology suite provides access to clinical reports and images via computer networks. Given the following information objects, the JPACS radiology suite may be used on any part of the human anatomy: CR, CT, MR, XA, SC, US, NM, PET, and RT. The suite also provides short, medium, and long term storage of these clinical images from any authorized workstation within an intranet or over the Internet. The full feature imaging suite can be used for in-house image distribution, on-call teleradiology, and advance visual display features. The JPACS radiology suite also includes functionality for generation and distribution of clinical reports.
    Device Description
    The JPACS radiology suite is intended to provide access to clinical reports and images via computer networks. It is also intended to provide short, medium and long range storage of clinical images from any authorized workstation within an intranet or over the Internet. The full feature imaging suite can be used for in-house image distribution, on-call teleradiology, and advance visual display features. The JPACS radiology suite also includes functionality for generation and distribution of clinical reports. Picker adheres to FDA 21 CFR 820 and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1. The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of operation are equivalent. External communication uses DICOM V. 3.0 NEMA Standards Publication Parts PS3.1 through PS3.13, dated 1996.
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    K Number
    K974882
    Device Name
    DOWNSCAN LT
    Manufacturer
    MERLIN ENGINEERING WORKS, INC.
    Date Cleared
    1998-05-22

    (143 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Product Code :

    LMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal (30 or 25 frames/second) is required. Examples include conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, or disk recorders, or other apparatus requiring a standard frame rate signal.
    Device Description
    DownScan LT is a digital image processing system that can convert from high line rate video standard of 1023-1125/60 or 1249/50 to low line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA half-rack mount chassis, DownScan LT operates from 100V to 240V AC power.
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