nordicDSC 23.04
nordicDSC 23.04, a MRI system application software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Nordicneurolab AS, was cleared under FDA 510(k) K212720 on 3 Mar 2022 and listed in FDA GUDID on 12 Feb 2024 (UDI-DI 07090042059053); the registry lists it as not in commercial distribution (GUDID) as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07090042059053 | Date12 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212720 | Date3 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 07090042059053
- FDA 510(k) database K212720
Across registries
- FDA 510(k) K212720 decided 3 Mar 2022 Active
- FDA GUDID UDI-DI 07090042059053 listed 12 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K212720
- Listed FDA GUDID 07090042059053
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- nordicDSC
- Generic name
- MRI system application software
- Model / reference
- 23.04
- Primary DI / UDI-DI
- 07090042059053
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under MRI system application software.