FDA.reportPublic FDA data

EasyViz

Primary DI
62810500000024
Brand
EasyViz
Company
Canon Medical Informatics A/S
Model
7.2
Device description
EsayVIz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologist, Cardiologists, Clinicians and referring Physicians.
Published
2016-08-02
Public version status
Update
Distribution status
Not 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
K051809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051809000EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEMMedical Insight A/S2005-08-15LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
62810500000024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6281050000002462810500000024

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
307092283
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628105001212Vitrea Read9.1.22026-04-27
00628105001229Vitrea Read8.5.92026-04-03
00628105001205Vitrea Read8.5.82025-11-21
00628105001168Vitrea Read9.1.09.1.1-376.el9.final - 2025-08-212025-01-10
00628105001199Vitrea Read8.5.72025-08-15
00628105001182Vitrea Read8.5.62025-04-04
00628105001175Vitrea Read8.5.52025-01-10
00628105001151Vitrea Read9.0.12024-05-22
00628105001144Vitrea Read8.5.42024-04-03
00628105001106Vitrea Read9.0.02024-01-19
00628105001120Vitrea Read8.4.62024-01-19
00628105001137Vitrea Read8.5.32023-11-28
00628105001113Vitrea Read8.5.22023-11-08
00628105001090Vitrea Read8.4.52023-09-21
00628105001045Vitrea Read8.5.02023-09-18
00628105001076Vitrea Read8.5.12023-09-18
00628105001052Vitrea Read8.4.32023-03-06
00628105001038Vitrea Read8.4.22022-11-04
00628105001021EasyViz8.3.92022-10-21
00628105001007Vitrea Read8.42022-04-22

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Primary DI, Brand, Company table
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08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
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08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
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