FDA UDI In Commercial Distribution 🇺🇸 United States

EasyViz

DI: 00628105001748 · Model: 7.4 · Canon Medical Informatics A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EasyViz
Primary DI
00628105001748
Version / Model
7.4
Company Name
Canon Medical Informatics A/S
Labeler DUNS
307092283
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-09-15
Public Version
7
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
8f4c628b-9b30-494a-96a5-b0eba7b731bc

Device Description

EasyViz 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 Radiologists, Cardiologists, Clinicians and referring Physicians.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary 00628105001748

Premarket Submissions

Submission Number Supplement Number
K051809 000