Vitrea Advanced Visualization
Canon Medical’s Vitrea Advanced Visualization is a multi-modality software suite for processing and analyzing clinical images. Its applications work with CT, MR, X-ray angiography, PET,…
Canon Medical’s Vitrea Advanced Visualization is a multi-modality software suite for processing and analyzing clinical images. Its applications work with CT, MR, X-ray angiography, PET, ultrasound and SPECT data, with two-dimensional, three-dimensional and four-dimensional views. The suite brings image-processing applications into clinical workflows across several specialties.
Its range includes dedicated tools rather than one universal application. For example, CT VScore visualizes and measures coronary calcification, while CT Brain Perfusion presents perfusion maps and flow views for brain-image review. Availability depends on the selected Vitrea applications and configuration.
Application Examples
Cardiac applications include calcium scoring and planning tools for transcatheter aortic valve replacement. Neuro applications include automated alignment of brain CT multiplanar views and perfusion visualization. Each tool processes a particular image set for a defined review task.
Canon also describes application suites for vascular, oncology and musculoskeletal imaging. These examples illustrate the breadth of the product family; they are separate tools and workflows within the larger suite.
Who Else Makes It
Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| AUO (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Beijing Visual Perception Intelligence Technology Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
| E-COM Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Canon Medical Informatics, Inc., United States |
|---|---|
| FDA product code | LMD |
| Device type | System, Digital Image Communications, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2020 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K032748 |
| Record published | 2023-09-11 |
| Record revised | 2023-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7.15.7 | In distribution | |
| 7.12.6 | In distribution | |
| 7.11.4 | In distribution | |
| 7.15.1 | In distribution | |
| 7.15 | In distribution | |
| 7.11.2 | In distribution | |
| 7.14.2 | In distribution | |
| 7.12.5 | In distribution | |
| 7.14.5 | In distribution | |
| 7.15.6 | In distribution | |
| 7.12.2 | In distribution | |
| 7.12.1 | In distribution | |
| 7.15.3 | In distribution | |
| 7.12.3 | In distribution | |
| 7.16.0.SU01 | In distribution | |
| 7.15.5 | In distribution | |
| 7.15.8.SU01 | In distribution | |
| 7.16.0.SU02 | In distribution | |
| 7.16.0.SU04 | In distribution | |
| 7.16.2.SU01 | In distribution | |
| 7.14 | In distribution | |
| 7.15.8 | In distribution | |
| 7.12.4 | In distribution | |
| 7.16.0 | In distribution | |
| 7.14.6 | In distribution | |
| 7.16.0.SU03 | In distribution | |
| 7.12 | In distribution | |
| 7.16.1 | In distribution | |
| 7.14.3 | In distribution | |
| 7.14.4 | In distribution | |
| 7.15.4 | In distribution | |
| 7.15.2 | In distribution | |
| 7.16.2 | In distribution | |
| 7.14.1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Barco | Barco, Inc | 27 |
| RadiForce® | Eizo Corporation | 23 |
| Vitrea Read | Canon Medical Informatics A/S | 19 |
| Image Diagnostics, Inc | Image Diagnostics, Inc. | 19 |
| ScaleOR | NDS Surgical Imaging, LLC. | 17 |
| interWORKS | Avreo, Inc. | 16 |
| Vitrea View | Canon Medical Informatics, Inc. | 14 |
| Clinical review 2MP | Barco, Inc | 11 |
| Barco | Fimi SRL | 10 |
| Super Ulstar | Durico C&T, Inc. | 9 |
| VISIUSmatrix | Imris Imaging, Inc. | 9 |
| Lilly Together | Eli Lilly and Co. | 8 |
Showing 12 of 193. All products under System, Digital Image Communications, Radiological
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Canon Medical Informatics, Inc. | 510(k) number | 2013-10-21 | Class II | Software design | Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 | 598 | 2015-01-16 |
| Canon Medical Informatics, Inc. | 510(k) number | 2013-03-15 | Class II | Software design | Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table unde | 102 | 2015-02-27 |
| Canon Medical Informatics, Inc. | 510(k) number | 2013-03-15 | Class II | Labeling design | Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This | 1,978 | 2015-04-08 |
| Canon Medical Informatics, Inc. | 510(k) number | 2012-08-13 | Class II | Software design | Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6 | 2088 (1133 USA) | 2015-03-25 |
| Canon Medical Informatics, Inc. | 510(k) number | 2011-11-11 | Not classified | Software design | Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all up | 338 (233 US) | 2013-12-03 |
| Canon Medical Informatics, Inc. | 510(k) number | 2010-08-23 | Not classified | Software design | There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than | 178 | 2012-11-06 |
| Canon Medical Informatics, Inc. | 510(k) number | 2007-11-08 | Not classified | Process control | Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the | 18 | 2011-12-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.