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
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
00856100006493Respiratory Gating for ScannersVARIAN MEDICAL SYSTEMS, INC.JAK2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13