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510(k) Data Aggregation

    K Number
    K161270
    Device Name
    CephSimulation
    Manufacturer
    ANATOMAGE, INC
    Date Cleared
    2017-01-04

    (244 days)

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

    ANATOMAGE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.
    Device Description
    CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen. CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.
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    K Number
    K123519
    Device Name
    INVIVO DENTAL
    Manufacturer
    ANATOMAGE, INC
    Date Cleared
    2013-02-01

    (78 days)

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

    ANATOMAGE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In VivoDental is a software application used 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, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, In VivoDental is a preoperative software application used for the simulation of dental implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use.
    Device Description
    InVivoDental is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The software is downloaded over the internet and installed on the customer's computer. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing. There are several rendering settings to emphasize bone and/or soft tissue. The software also has the ability to create panoramic images, superimpose images, and create measurements of volume, angle, and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. The software has specialized tools to simulate surgical treatments using models rendered by Antomage, and any view or user modified area can be saved to a gallery. These simulations and galleries can then be reviewed by medical personnel or used for consultation between the doctor and patient.
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    K Number
    K070803
    Device Name
    INVIVODENTAL
    Manufacturer
    ANATOMAGE, INC
    Date Cleared
    2007-04-06

    (14 days)

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

    ANATOMAGE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment
    Device Description
    InVivoDental is a volumetric imaging software designed specifically for dental clinicians. The software reads DICOM data from dental CT machines including I-CAT, NewTom, MecuRay and Accuitomo. The software runs in Windows XP operating system and visualizes the DICOM data on the computer screen. The software is downloaded over the internet and installed on the customer's computer.
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