nordicBrainEx
- Primary DI
- 07090042059015
- Brand
- nordicBrainEx
- Company
- Nordicneurolab AS
- Model
- 2.3
- Device description
- The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focuson ease of use and high performance on a standard Windows workstation. The software providescomprehensive functionality for dynamic image analysis and visualization of MRI data, where signalchanges over time are analyzed to determine various modality dependent functional parameters. Thefollowing algorithms provide the main functional analyses of the application.- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in thehuman 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 ofdiffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusionto display the white matter structure in the brain.- DSC: Calculations of perfusion related parameters that provide information about the bloodvessel structure and characteristics. Examples of such maps are blood volume, blood flow, timeto 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 theapplication is optimized to ensure efficiency and high throughput in a clinical environment.
- Published
- 2017-05-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K163324 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07090042059015 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07090042059015 | 07090042059015 | 7090042059015 |
GMDN Terms#
| Term | Definition |
|---|---|
| MRI system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +4755707095 | ProductSolutions@nordicneurolab.com |
Regulatory Flags#
- DUNS number
- 671280238
- Device count
- 1
- Lot or batch
- true
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| 07090042053051 | BatteryBox | 1.0 | 2026-04-01 | |
| 07090042053068 | HeadSet 3T | 1.0 | 2026-04-01 | |
| 07090042053075 | BatteryCharger | 1.0 | 2026-04-01 | |
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| 07090042053099 | AudioHub | 1.0 | 2026-04-01 | |
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| 07090042059053 | nordicDSC | 23.04 | 2024-02-12 | |
| 07090042052078 | VisualSystem Power Cable (VPC) | 1.1 | 2021-01-29 | |
| 07090042052108 | Visual System HD | VHD-1.2 | 2021-01-29 | |
| 07090042052061 | Control Room Interface | CRI-1.0 | 2020-03-01 | |
| 07090042052085 | Visual System HD | VHD-1.1 | 2020-03-01 | |
| 07090042052092 | Visual System Power Supply | VPS-1.1 | 2020-03-01 | |
| 07090042054041 | ResponseGrip Interface | RGI-2.2 | 2019-10-24 | |
| 07090042054058 | SyncBox | SB- 3.2 | 2019-10-24 | |
| 07090042051057 | LCD Power Supply | LPS-3.1 | 2019-06-27 | |
| 07090042051033 | Inroom Viewing Device | LDC 3.0 | 2016-09-24 | |
| 07090042051040 | LCD Power Supply | LPS 3.0 | 2016-09-24 | |
| 07090042052016 | Coil Mounted Display | CMD 2.3 | 2016-09-24 |
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