Vitrea

Primary DI
00853866003179
Brand
Vitrea
Company
Canon Medical Informatics, Inc.
Model
6.9
Device description
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser.Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
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
K040305000
K043333000
K052632000
K071331000
K071362000
K072821000
K121213000
K122578000
K140395000
K141302000
K143079000
K150104000
K151919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032748000VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWAREVital Images, Inc.2003-10-29LLZ
K040305000VITREA2 VERSION 3.5Vital Images, Inc.2004-02-24LLZ
K043333000VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEMVital Images, Inc.2004-12-15LLZ
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
K151919000Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.2015-10-10JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003179008538660031798538660031790853866003179

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
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
00850025268202Vitrea Advanced Visualization 7.15.72023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08719326703824LungQ®Thirona B.V.JAK2026-02-12