Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nordicimaginglab AS · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092102 | NORDICBRAINEX SOFTWARE, VERSION 1.0 | Nordicimaginglab AS | 2009-08-25 | 42 | 0 |
| K090546 | MODIFICATION TO NORDICICE SOFTWARE | Nordicimaginglab AS | 2009-06-08 | 98 | 0 |
| K082441 | NORDICICE SOFTWARE | Nordicimaginglab AS | 2008-11-21 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda