Vitrea Advanced Visualization

GUDID 00853866003858

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server

VITAL IMAGES, INC.

Radiology PACS software
Primary Device ID00853866003858
NIH Device Record Key1c62bb80-948f-4580-9cb9-91a7621ce73c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitrea Advanced Visualization
Version Model Number7.13
Company DUNS160061651
Company NameVITAL IMAGES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853866003858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

On-Brand Devices [Vitrea Advanced Visualization ]

00853866003681The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003414The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003384The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003360The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003339The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003322The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003667The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003742The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003797The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003803The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003759The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003841The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003872The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003865The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003827The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003773The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003766The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003889The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003858The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003902The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003957The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003971The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003995The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003940The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00853866003988The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268004The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268011The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268042The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268035The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268097The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
00850025268066The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
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