nordicBrainEx
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software…
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application. – BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. – DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. – DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage. In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Nordicneurolab AS, Norway |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K163324 |
| Record published | 2017-05-07 |
| Record revised | 2023-03-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243209 | 2024-10-22 |
| K241608 | 2024-06-28 |
| K212720 | 2022-03-03 |
| K163324 | 2017-01-27 |
| K133910 | 2014-04-04 |
| K123306 | 2013-05-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nordicneurolab AS | UDI-DI | 2022-06-16 | Class II | Software design | When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped. | 243 units | 2024-09-04 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-07-03 | Class II | Software design | The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration. | 121 licenses | 2020-09-16 |
| 2014-12-15 | Class II | Software design | An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images. | 16 licenses | 2021-03-24 |
| 2014-09-17 | Class II | Software design | An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images. | 22 licenses | 2021-03-24 |
| 2014-09-12 | Class II | Software design | An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images. | 97 licenses | 2020-10-06 |
| 2012-12-21 | Class II | Software design | There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. | 36 licenses | 2020-09-16 |
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.