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510(k) Data Aggregation

    K Number
    K113543
    Device Name
    ONDEMAND3D
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2011-12-16

    (15 days)

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

    CYBERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OnDemand3D92 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It also provides the following functions as shown below. - 1) Functions for implant surgery planning and fabricating a surgical guide according to the plan - 2) Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time - 3) Functions to create orthodontic analysis using 3D volume data - 4) Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name
    Device Description
    OnDemand3DS2 is a personal computer based dental imaging software which I oads DICOM images taken from CT, MR and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It is also intended to plan an implant surgery, fabricate a surgical guide according to the plan, superimpose and stitch multi DICOM da ta sets, mark anatomical landmark from CT data and provide analyzed data for orthodontic treatment while software provides 2D image viewing module enabli ng 2D image acquisition specialized in 2D scanned image supporting DICOM, BITMAP, JPG, TIF. OnDemand3D22 is designed to provide with users and familiar user-interface easy. Also OnDemand3D22 makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.
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    K Number
    K070464
    Device Name
    ONDEMAND3D
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2007-03-16

    (28 days)

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

    CYBERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OnDemand3D™ is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
    Device Description
    OnDemand3D™ is a personal computer based dental imaging software which loads DICOM images taken from CT, MR and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. OnDemand3D™ is designed to provide users easy and familiar user-interface. Also OnDemand3D™ makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.
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    K Number
    K061126
    Device Name
    ACCUREX
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2006-05-09

    (15 days)

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

    CYBERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use as a software for the display and 3D visualization of dental image files from scanning devices such as CT, MRI for radiologists, dental clinicians and practitioners to acquire, process, render, review, store, print and distribute DICOM 3.0 complaint image studies, utilizing standard PC hardware.
    Device Description
    Accurex™ is a dental imaging software which loads DICOM images taken from CT. MR and provides 3D visualization, 2D image reformation and various diagnosis tools for dentists on PC, laptop or PACS Workstation. Dentists can do further precise and accurate pre/post-operative diagnosis by using advanced image reformation and generation functionality of Accurex™ such as Panoramic image and Cephalometric x-ray imaqe as well as 3D volume rendering image.
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    K Number
    K053155
    Device Name
    VIMPLANT
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2005-11-23

    (9 days)

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

    CYBERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vimplant is intended for use as a software interface for the transfer of imaging information from a CT scanner and also as a pre-operative software for simulation and evaluation dental implant placement and surgical treatment options.
    Device Description
    VImplant™ is a dental implant simulation software for dentists and implantologists. By use of VImplant™, dental practicians can plan and practice their surgery in advance so they can reduce some risks which can happen during their real surgery. Vimplant™ provides very useful and needful functions. It contains functions of implant simulation, manipulation with 2D and 3D mode, nerve identification, and evaluation of bone density. By using Vimplant TM, dental practicians can quickly and easily simulate implant surgery on their desktop PCs. This enables them to conduct implant surgery more effectively by isolating the exact implant position site and angle and to assist in deciding the proper implant diameter, length, etc.
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    K Number
    K013878
    Device Name
    CYBERMED, INC., V-WORKS
    Manufacturer
    CYBERMED, INC.
    Date Cleared
    2001-12-07

    (14 days)

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

    CYBERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-works is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
    Device Description
    The V-works™ is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, mocess, render, review, store, print and distribute DICOM 3.0 complaint image process, reliaer, 101107, 1011, 1978, dware. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft personal compacer pratessional/NT 4.0 operating system makes the V-works™ software easy to use and capable of being integrated with other computer needs.
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