FDA.reportPublic FDA data

Vitrea

Primary DI
00853866003216
Brand
Vitrea
Company
Canon Medical Informatics, Inc.
Model
7.3.2
Device description
Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity.
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032748000
K052632000
K071331000
K071362000
K072821000
K121213000
K122578000
K140395000
K141302000
K143079000
K150104000
K150258000
K151115000
K151283000
K151919000
K160150000
K161157000
K161419000

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
K072821000VITREA 4DCTVital Images, Inc.2008-02-20LLZ
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
K150258000Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.2015-03-05LLZ
K151115000MR Core SoftwareVital Images, Inc.2015-06-03LLZ
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
K161419000Multi Modality ViewerVital Images, Inc.2016-07-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003216008538660032168538660032160853866003216

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAK2026-07-08
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
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00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26