Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fluoptics Sas (A Getinge Group Company} · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging Syste | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 | 58 | 0 |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imagin | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 | 39 | 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