FDA.reportPublic FDA data

Vitrea Advanced Visualization

Primary DI
00850025268318
Brand
Vitrea Advanced Visualization
Company
Canon Medical Informatics, Inc.
Model
7.16.2
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
2025-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032748000
K052632000
K071331000
K071362000
K121213000
K122578000
K140395000
K141302000
K143079000
K150104000
K151283000
K151919000
K160150000
K161157000
K172855000
K181247000
K182230000
K222662000
K223261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032748000VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWAREVital Images, Inc.2003-10-29LLZ
K052632000VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWAREVital Images, Inc.2005-12-15LLZ
K071331000VITREA VERSION 4.0Vital Images, Inc.2007-05-25LLZ
K071362000VITAL CONNECT 4.1Vital Images, Inc.2007-05-30LLZ
K121213000VITREAADVANCEDVital Images, Inc.2012-11-02LLZ
K122578000VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNINGVital Images, Inc.2013-02-25LLZ
K140395000VITREA IMAGE DENOISING SOFTWAREVital Images, Inc.2014-05-13LLZ
K141302000VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)Vital Images, Inc.2014-08-01LLZ
K143079000Endovascular Stent Planning SoftwareVital Images, Inc.2014-12-04LLZ
K150104000Vitrea CT Myocardial PerfusionVital Images, Inc.2015-04-17JAK
K151283000Lung Analysis SoftwareVital Images, Inc.2015-10-30JAK
K151919000Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.2015-10-10JAK
K160150000Vitrea CT Colon AnalysisVital Images, Inc.2016-03-16LLZ
K161157000Vitrea CT Dual Energy Image ViewVital Images, Inc.2016-11-03JAK
K172855000Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.2017-10-05LLZ
K181247000Vitrea CT Brain PerfusionVital Images, Inc.2018-11-20LLZ
K182230000Multi Modality ViewerVital Images, Inc.2018-09-07LLZ
K222662000Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.2022-10-14LLZ
K223261000Open RibCanon Medical Informatics, Inc.2023-07-13JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025268318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025268318008500252683188500252683180850025268318

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
160061651
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025268431Vitrea Advanced Visualization7.16.52026-09-21
00850025268417Vitrea Advanced Visualization7.16.4.SU022026-06-05
00850025268257Vitrea Advanced Visualization7.16.12024-09-05
00850025268387Vitrea Advanced Visualization7.16.3.SU022025-11-03
00850025268424Vitrea Advanced Visualization7.16.3.SU032026-05-12
00850025268400Vitrea Advanced Visualization7.16.4.SU012026-02-27
00850025268394Vitrea Advanced Visualization7.16.42026-01-21
00850025268370Vitrea Advanced Visualization7.16.3.SU012025-09-24
00850025268349Vitrea Advanced Visualization7.16.32025-07-11
00850025268363Vitrea Advanced Visualization7.16.0.SU052025-06-03
00850025268356Vitrea Advanced Visualization7.16.2.SU022025-05-23
00850025268332Vitrea Advanced Visualization7.16.2.SU012025-05-16
00850025268325Vitrea Advanced Visualization7.16.0.SU042024-11-21
00850025268301Vitrea Advanced Visualization7.16.0.SU032024-09-20
00850025268295Vitrea Advanced Visualization7.16.0.SU022024-08-13
00850025268240Vitrea Advanced Visualization7.16.0.SU012024-05-02
00850025268233Vitrea Advanced Visualization7.16.02024-04-12
00850025268226Vitrea Advanced Visualization7.15.8.SU012024-01-29
00850025268219Vitrea Advanced Visualization7.15.82023-10-13
00850025268165Vitrea Advanced Visualization7.15.62022-12-14

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