Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imix Adr Finland OY · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113855 | PANORAD, PANORAD SL | Imix Adr Finland OY | 2012-01-25 | 27 | 0 |
| K101435 | IMIX PANORAD AND SOMARAD | Imix Adr Finland OY | 2010-09-15 | 117 | 0 |
| K073114 | IMIX INSIGHT X-RAY SYSTEMS | Imix Adr Finland OY | 2008-01-17 | 73 | 0 |
| K072867 | IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW | Imix Adr Finland OY | 2007-11-21 | 47 | 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