Vitrea Advanced Visualization

Primary DI
00853866003858
Brand
Vitrea Advanced Visualization
Company
Canon Medical Informatics, Inc.
Model
7.13
Device description
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
Published
2020-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121213000
K172855000
K181247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121213000VITREAADVANCEDVital Images, Inc.2012-11-02LLZ
K172855000Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.2017-10-05LLZ
K181247000Vitrea CT Brain PerfusionVital Images, Inc.2018-11-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003858008538660038588538660038580853866003858

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160061651
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025268417Vitrea Advanced Visualization7.16.4.SU022026-06-05
00850025268424Vitrea Advanced Visualization 7.16.3.SU032026-05-12
00850025268387Vitrea Advanced Visualization 7.16.3.SU022025-11-03
00850025268400Vitrea Advanced Visualization 7.16.4.SU012026-02-27
00850025268394Vitrea Advanced Visualization 7.16.42026-01-21
00850025268370Vitrea Advanced Visualization 7.16.3.SU012025-09-24
00850025268349Vitrea Advanced Visualization 7.16.32025-07-11
00850025268363Vitrea Advanced Visualization 7.16.0.SU052025-06-03
00850025268356Vitrea Advanced Visualization 7.16.2.SU022025-05-23
00850025268332Vitrea Advanced Visualization 7.16.2.SU012025-05-16
00850025268318Vitrea Advanced Visualization 7.16.22025-03-21
00850025268325Vitrea Advanced Visualization 7.16.0.SU042024-11-21
00850025268301Vitrea Advanced Visualization 7.16.0.SU032024-09-20
00850025268257Vitrea Advanced Visualization 7.16.12024-09-05
00850025268295Vitrea Advanced Visualization 7.16.0.SU022024-08-13
00850025268240Vitrea Advanced Visualization 7.16.0.SU012024-05-02
00850025268233Vitrea Advanced Visualization 7.16.02024-04-12
00850025268226Vitrea Advanced Visualization 7.15.8.SU012024-01-29
00850025268219Vitrea Advanced Visualization 7.15.82023-10-13
00850025268165Vitrea Advanced Visualization 7.15.62022-12-14

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