Device
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
Manufacturer
Canon Medical Informatics A/S
Canon Medical Informatics A/S
Model: 9.1.2
DI: 00628105001212
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
94223680-cbb1-4498-8517-f1a69cc2b86b
Distribution Status:
In Commercial Distribution
DUNS Number:
307092283
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00628105001212
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41670
Name: Radiological PACS software
Definition:
An 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.
FDA Product Codes
LMD
System, Digital Image Communications, Radiological