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Vitrea Advanced Visualization

FDA UDI

Class I (US FDA UDI)

by Canon Medical Informatics, Inc.

Identity

Trade Name
Vitrea Advanced Visualization FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
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 FDA UDI
Model / Reference
7.12.6 FDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI
00853866003995 FDA UDI
FDA Product Code
LMD FDA UDI
LLZ FDA UDI
JAK FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 FDA UDI
892.2050 FDA UDI
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

Vitrea Advanced Visualization by Canon Medical Informatics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Canon Medical Informatics, Inc.

Sources (1)

  • FDA UDI ea4d126b-1a7f-458a-9612-a6d3b230fa3a 33 fields · synced Jun 9, 2026