Device
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional di...
Manufacturer
Canon Medical Informatics, Inc.
Canon Medical Informatics, Inc.
Model: 7.16.3.SU03
DI: 00850025268424
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
• Retrieve image data over the network via DICOM
• Display of images in dedicated protocols which are automatically adapted based on exam type
• Select images for closer examination from a gallery of 2D or 3D views
• Interactively manipulate an image in real-time to visualize anatomy and pathology
• Annotate, measure, and record selected views
• Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
• Retrieve reports that are archived on a Web server
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b35bacfa-0df6-47d9-9b4e-0d47fb34d5e1
Distribution Status:
In Commercial Distribution
DUNS Number:
160061651
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850025268424
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
LLZ
System, Image Processing, Radiological
JAK
System, X-Ray, Tomography, Computed
LMD
System, Digital Image Communications, Radiological