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510(k) Data Aggregation
K Number
K090295Device Name
BODYVIZ, MODEL 100
Manufacturer
VISUAL MEDICAL SOLUTIONS, LLC
Date Cleared
2009-03-04
(27 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISUAL MEDICAL SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BodyViz is a software device that receives digital images and data from various sources (i.e. CT scanner, MRI scanners). Data must be in DICOM format. Images and data are parsed, stored, processed, and displayed within the system as 3D representations. Image tools are available such as translation, rotation, scaling, clipping, and coloring. A data tool is available to window the displayed representation to certain tissue types based on tissue density (e.g., muscle, bone, or skin). Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.
Device Description
BodyViz is a software based application for creating 3D models of patient data from 2D scan slices. Users have the ability input, display, color, and manipulate the 2D scan slices via a 3D representation. BodyViz is a visualization environment that allows surgeons to plan various types of surgery on their patient data in 3D. BodyViz works with any, DICOM formatted 2D image scan slices. Data can be accessed from internal and external data storage devices, as well as network and CD/DVD data sources. The software runs on any modern Windows based computer (i.e. laptop or desktop) with a 3D graphics card that meets minimum requirements, eliminating the need for specialized hardware. BodyViz is a medical device image software that is used with computer hardware in a typical hospital or clinic networked computer environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing sufficient opportunity for competent human intervention, interprets images and information being displayed.
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