FDA UDI
In Commercial Distribution
🇺🇸 United States
nordicDSC
DI: 07090042059053
·
Model: 23.04
·
Nordicneurolab AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- nordicDSC
- Primary DI
- 07090042059053
- Version / Model
- 23.04
- Company Name
- Nordicneurolab AS
- Labeler DUNS
- 671280238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-12
- Public Version
- 1
- Public Version Date
- 2024-02-20
- Public Version Status
- New
- Public Device Record Key
- 223383d9-5e93-40ca-993f-40f7ce785b76
Device Description
nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40872 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090042059053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212720 | 000 |