FDA UDI In Commercial Distribution 🇺🇸 United States

Vitrea View

DI: 00850025268141 · Model: 7.8 · Canon Medical Informatics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vitrea View
Primary DI
00850025268141
Version / Model
7.8
Company Name
Canon Medical Informatics, Inc.
Labeler DUNS
160061651
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-26
Public Version
2
Public Version Date
2023-10-18
Public Version Status
Update
Public Device Record Key
b623dbcd-6a06-4514-ad97-d77cca26ba96

Device Description

Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and Multi-Media medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images from 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 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 with access to clinical reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians, clinicians and other medical professionals. The Vitrea View software is scalable due to the web-based zero-footprint architecture which allows sites to quickly and easily add new users as demand grows. The software may also be deployed in a virtualized environment.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LMD System, Digital Image Communications, Radiological

GMDN Terms

Code Name
41670 Radiological PACS software

Identifiers

Type ID
Primary 00850025268141