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510(k) Data Aggregation
K Number
K094064Device Name
ILUMA VISION MODEL VERSION 2.2
Manufacturer
Date Cleared
2010-04-30
(120 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
3M IMTEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.
It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.
Additionally, ILUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
ILUMAVision is not intended for use with mammography.
Device Description
ILUMAVision is an image management software application used for the display and 3D visualization of medical image files obtained from scanning devices, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or three-dimensional (3D) ultrasound.
ILUMAVision uses image filtering, 3D reconstruction and quantitative algorithms to view, measure, and annotate images. ILUMA Vision can be used to make panoramic images and to monitor treatment progress, capture images, bookmark certain items in a treatment, generate and edit reports, and export datasets. The application can also query and import images directly from a Picture Archiving and Communication System (PACS) over a TCP/IP network.
It distributes DICOM 3.0 compliant images, using standard personal computer (PC) hardware. Images can also be saved in JPEG format.
The software is intended to run on a personal computer (PC).
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