DEVICE: Vitrea Advanced Visualization (00853866003384)
Device Identifier (DI) Information
Vitrea Advanced Visualization
7.9
In Commercial Distribution
Canon Medical Informatics, Inc.
7.9
In Commercial Distribution
Canon Medical Informatics, Inc.
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
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 41670 | Radiological PACS software |
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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
| JAK | System, X-Ray, Tomography, Computed |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K032748 | 000 |
| K052632 | 000 |
| K071331 | 000 |
| K071362 | 000 |
| K121213 | 000 |
| K122578 | 000 |
| K140395 | 000 |
| K141302 | 000 |
| K143079 | 000 |
| K150104 | 000 |
| K151283 | 000 |
| K151919 | 000 |
| K160150 | 000 |
| K161157 | 000 |
| K163574 | 000 |
| K172855 | 000 |
| K182230 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2514e014-4b1a-4557-be6f-f11dbfb25863
October 18, 2023
6
August 15, 2018
October 18, 2023
6
August 15, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined