Vitrea View

Primary DI
00853866003353
Brand
Vitrea View
Company
Canon Medical Informatics, Inc.
Model
7.1.4
Device description
Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the web-based zero-footprint nature of the Vitrea View software. The Vitrea View software offers scalability to add new users as demand grows, may be deployed in a virtualized environment.
Published
2017-12-21
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
K163232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163232000Vitrea ViewVital Images, Inc.2017-07-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003353008538660033538538660033530853866003353

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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