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510(k) Data Aggregation
K Number
K161559Device Name
Kuvia3D
Manufacturer
4QIMAGING, LLC DBA QMETRICS
Date Cleared
2016-06-23
(17 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
4QIMAGING, LLC DBA QMETRICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.
Device Description
Kuvia3D is a software system used to display, analyze and generate three-dimensional visualizations of DICOM image data. The software is supported on an off-the-shelf personal computer system platform running the Microsoft Windows operating system. The user will transfer medical image data to the Kuvia3D system from a DICOM image system (such as a PACS) and proceed to use Kuvia3D's viewing and segmentation tools to segment the image data as desired. Once the user has completed segmenting the image data, they can convert the segmented region to a 3D rendered surface and adjust the view of the segmented anatomy as desired. Linear measurements may be taken in the 2D image as well as the 3D surface rendering. Screen captures of the 3D surface rendering window mav be saved as derivative images and appended to the imaging study, or transferred to other DICOM image systems.
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