FDA.reportPublic FDA data

EasyViz

Primary DI
00628105001021
Brand
EasyViz
Company
Canon Medical Informatics A/S
Model
8.3.9
Device description
EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628105001021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628105001021006281050010216281050010210628105001021

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
307092283
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628105001205Vitrea Read8.5.82025-11-21
00628105001212Vitrea Read9.1.22026-04-27
00628105001229Vitrea Read8.5.92026-04-03
00628105001199Vitrea Read8.5.72025-08-15
00628105001182Vitrea Read8.5.62025-04-04
00628105001168Vitrea Read9.1.09.1.1-376.el9.final - 2025-08-212025-01-10
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
00628105001007Vitrea Read8.42022-04-22
00628105001823EasyViz8.22021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-09-21
05415334059139BarcoBarco NVLMD2026-09-21
05415334059924BarcoBarco NVLMD2026-09-21
05415334059931BarcoBarco NVLMD2026-09-21
04056481144616Quip EyeBrainlab SELMD2026-08-25
04056481145804Brainlab Origin ORBrainlab SELMD2026-08-21
00850054590183interWORKSAvreo IncLMD2026-08-03
00850054590176interWORKSAvreo IncLMD2026-07-29
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
00850054590169interWORKSAvreo IncLMD2026-07-08
B214CORELABV100CORELabmedimaps group SALMD2026-06-29
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21