nordicBrainEx
Basic Information
- Primary DI
- D-nordicBrainExSY
- Basic UDI-DI Code
- B-nordicBrainExSY
- Reference
- 2.3
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- NordicNeuroLab AS
Additional Description
nordicBrainEx is an advanced visualization and processing software, with specific focus on providing algorithms designed to analyze functional MR data of the brain. The software runs on a standard "off-the-shelf" PC workstation and can be used with data and images acquired through DICOM compliant imaging devices and modalities. The software is intended to be used by medical personnel, such as radiologists or medical technicians, trained in the methods provided by the application. In order to best accommodate this group of users, it is specifically designed to have an easy to use and streamlined workflow, as well as an intuitive graphical user interface.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11020792 | INTEGRATED MRI/PET SYSTEMS - MEDICAL DEVICE SOFTWARE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434--MDD-242/2019 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).