Nordicneurolab AS: FDA clearances and approvals
Nordicneurolab AS has 7 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 103 days. Since 2017 its median was 103 days, against 119 days for all cleared 510(k)s in the same product codes. openFDA lists 8 product recalls by a recalling firm named Nordicneurolab AS.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 63 |
| 2018 | 0 | — |
| 2019 | 1 | 223 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 188 |
| 2023 | 1 | 103 |
| 2024 | 2 | 22 |
| 2025 | 0 | — |
| 2026 | 1 | 269 |
Review time against the same product codes
Since 2017, Nordicneurolab AS's cleared 510(k)s took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
Review panels
- Radiology (7)
Most recent Nordicneurolab AS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251937 | nordicAudio (1.0) | LNH | 2026-03-20 | 269 |
| K243209 | nordicMEDiVA | LLZ | 2024-10-22 | 21 |
| K241608 | nordicMEDiVA | LLZ | 2024-06-28 | 24 |
| K232680 | fMRI Hardware System | LNH | 2023-12-13 | 103 |
| K212720 | nordicDSC | LLZ | 2022-03-03 | 188 |
| K191032 | fMRI Hardware System | LNH | 2019-11-27 | 223 |
| K163324 | nordicBrainEx | LLZ | 2017-01-27 | 63 |
Recalls
8 product recalls in 8 recall events; 1 initiated in the last five years. Most recent: 2022-06-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Nordicneurolab AS's product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Nordicneurolab AS have?
Nordicneurolab AS has 7 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Nordicneurolab AS's 510(k)s?
The median time from FDA receipt to decision across Nordicneurolab AS's cleared 510(k)s is 103 days. Since 2017: 103 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Nordicneurolab AS make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 4); LNH (System, Nuclear Magnetic Resonance Imaging, 3).
Has Nordicneurolab AS had device recalls?
openFDA lists 8 product recalls in 8 recall events by a recalling firm whose name matches Nordicneurolab AS; the most recent began 2022-06-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Nordicneurolab AS clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Nordicneurolab AS's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.