Chrysalis Intelligence · Sponsors · Nordicneurolab AS

Nordicneurolab AS

Bergen, NO · 5 510(k) clearances · 1 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

5

2022-03-03 → 2026-03-20

Last 12 months

1

Product codes

2

Most recent

2026-03-20

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LLZ	System, Image Processing, Radiological	Class II	Radiology	3	2024-10-22
LNH	System, Nuclear Magnetic Resonance Imaging	Class II	Radiology	2	2026-03-20

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

0

Most recent

2022-06-16

Date	Severity	Status	Recall #	Product	Code	Reason
2022-06-16	Class II	Terminated	Z-1462-2022	nordicBrainEX, software versions 2.21 through 2.3.10	—	When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, th…

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2026-03-20	K251937	nordicAudio (1.0)	LNH	Class II	Radiology
2024-10-22	K243209	nordicMEDiVA	LLZ	Class II	Radiology
2024-06-28	K241608	nordicMEDiVA	LLZ	Class II	Radiology
2023-12-13	K232680	fMRI Hardware System	LNH	Class II	Radiology
2022-03-03	K212720	nordicDSC	LLZ	Class II	Radiology