Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K182815
    Device Name
    XVWeb 3D
    Manufacturer
    Apteryx, Inc.
    Date Cleared
    2018-11-30

    (58 days)

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

    Apteryx, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XVWeb 3D is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral radiological images using an internet/web browser. A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations. Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database. XVWeb 3D is compatible with programs that run on standard "offthe-shelf" personal computers, business computers, and servers running standard operating systems. The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes. XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.
    Device Description
    XVWeb 3D is an add-on software module for XVWeb (K132342) that enables dental practices to query and access digitally stored, 3D hard- and soft-tissue cone beam CT images using an internet/web browser. XVWeb 3D uses the web-based interface provided by XVWeb to display patient 3D images and studies. XVWeb 3D allows users to manipulate 3D images an infinite number of ways, allowing the dental anatomy to be viewed from every possible perspective, providing the information needed to plan efficient treatments. XVWeb 3D also allows users to enhance images (e.q., increase or decrease brightness/contrast, gamma correction), and add measurement labels to 3D patient images/studies for diagnostic purposes, and view the image's DICOM information entities. XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental cone beam CT images of the teeth, jaw, and lower skull area for diagnostic purposes only. The patient population are those who have had a dental cone beam CT examination. XVWeb 3D does not function by itself (i.e., it is not standalone software that can be launched and ran), it is integrated with XVWeb to query/access/view/ patient 3D images. XVWeb 3D is not required for XVWeb, it is an extra-cost option available to those who wish to add 3D-imaging capability to their existing XVWeb workflow. XVWeb 3D does not perform any radiographic image acquisition.
    Ask a Question
    K Number
    K132342
    Device Name
    XVWEB
    Manufacturer
    APTERYX, INC.
    Date Cleared
    2013-12-20

    (147 days)

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

    APTERYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XVWeb is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral radiological images using an internet/web browser. A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations. Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb database. XVWeb is compatible with programs that run on standard "off-the-shelf personal computers, business computers, and servers running standard operating systems. The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase or decrease brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes. XVWeb is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.
    Device Description
    XVWeb is a web-based dental picture archiving and communications system that provides a dental facility the ability to access their patient radiological image library over the internet. It is designed for deployment in medium to large dental facilities with multiple viewing stations and/or across remote sites using standard TCP/IP network infrastructures. The system uses a web-based interface that allows users to display patient images and studies in commercially available web browsers such as Internet Explorer, Mozilla, Firefox, or Google Chrome. XVWeb includes features for dental practices to: manipulate, enhance, add lahels, annotations to patient images/studies, and other relevant operations for diagnostic purposes. XVWeb includes image acquisition capabilities via integration with DICOM-compatible imaging systems that facilitate the production of original images. All images available for viewing in XVWeb have been received from DICOM compliant modalities or systems.
    Ask a Question
    K Number
    K983111
    Device Name
    XRAY VISION
    Manufacturer
    APTERYX, INC.
    Date Cleared
    1998-11-16

    (73 days)

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

    APTERYX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Uses for XrayVision in the dental industry are as follows: - Permits sending of data by email, client/server, ftp, phone and floppy disk . - Organize and archive x-rays and patient related files . - Facilitate sharing and transmission of information between doctors, other applications and other computers - Ability to place markers and annotations on x-rays for diagnostic purposes . - Allows user to take calibrated measurements . - Provide image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images). - Electronic transmission of images to insurance companies or specialist . When using XrayVision for diagnostic purposes the general public will be the doctor/dentist population. This software is primarily used to store a patient's imaging data (i.e. x-rays) in a form compatible with today's networked online practice management software. This software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.
    Device Description
    XrayVision is a software package designed to work with standard PC compatible computers capable of running Windows 95 or higher (32-bit operating systems). This software is designed to be a fully functional digital radiograph scanning, archiving, electronic transmission and diagnostic review system. XrayVision permits the acquisition of images directly from commercially available scanners, digital cameras, intra-oral cameras, etc. Once an image has been converted into digital form, Xray Vision permits the user to easily organize and archive digital radiographs, images, and other patient related files to various archiving media (e.g. removable media, storage servers, hard drives, etc.). XrayVision provides tools that permit the user to enhance images and place markers and annotations on radiographs to aid in the diagnostic process. The image enhancements provided by this software package utilize industry standard algorithms that do not result in the alteration of an image's or a radiograph's content. Unlike a direct digital system, XrayVision does not control the x-ray taking system and does not generate x-ray images directly from the physical world (XrayVision processes images and radiographs produced from other devices and physical media). XrayVision only permits enhancing radiographs for diagnostic purposes and does not allow the introduction of false data or the modification of the images and radiographs in any way. To facilitate better correlation of information with images, XrayVision permits direct association of custom information with an image. Using these associations the user is able to relate doctor information, a patient's information, procedure, etc. with an image. When an image is transferred to another location, these associations guarantee that the correct information is always associated with an image (it is stored along with the image). Electronic transmission capabilities are provided so that images can be sent to specialists and insurance companies for claims processing and diagnostic review. To ensure the originality and security of information, XrayVision contains security features such as digital signatures, encrypted transfers, image tracking and password protection to keep radiographs and other information safe from others and to prevent image modifications.
    Ask a Question

    Page 1 of 1