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510(k) Data Aggregation
K Number
K181926Device Name
InVivo Web Viewer
Manufacturer
Anatomage Inc.
Date Cleared
2018-09-21
(65 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Anatomage Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, assist in diagnosis, utilizing web user interface. Additionally, InVivo Web Viewer is a preoperative software application used for the planning and evaluation of dental implants and surgical treatments. This device is not indicated for mammography use.
Device Description
InVivo Web Viewer is an imaging software designed specifically for clinicians, doctors, physicians and other qualified medical professionals. It is used for the visualization of patient image files from scanning devices, such as CT and MRI, and for assisting in case diagnosis, dental implant placement and treatment planning. It displays 2D image and renders 3D volumetric image in web browser environment such as Google Chrome or Mozilla Firefox. Users are able to examine anatomy on a computer screen and manipulate the rendered image by turning, zooming, clipping, adjusting brightness and contrast and choosing different rendering color presets. User can also make distance measurements on the image and use the implant placement tool for assisting implant placement and surgical treatment planning.
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K Number
K150976Device Name
Collage
Manufacturer
ANATOMAGE INC.
Date Cleared
2015-06-04
(52 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ANATOMAGE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.
Device Description
Collage is an interactive imaging software used for the visualization, storage, and management of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Doctors, dental clinicians, and other qualified individuals can retrieve, process, render, review, store and print images, utilizing standard PC hardware. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The Collage software is intended as a platform bridging different sets of patient data for comprehensive studies. With Collage software, doctors can manage all of their patient images, including both 2D and 3D image data, in a single software.
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K Number
K140093Device Name
TABLE
Manufacturer
ANATOMAGE INC.
Date Cleared
2014-03-07
(52 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ANATOMAGE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, and assist in diagnosis, utilizing standard PC hardware.
This device is not indicated for mammography use.
Device Description
Table 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. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes.
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