Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekta, Inc. — 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) |
|---|---|---|---|---|---|
| K190178 | Monaco RTP System | Elekta, Inc. | 2019-03-29 | 56 | 0 |
| K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018-12-04 | 33 | 0 |
| K183037 | Monaco RTP System | Elekta, Inc. | 2018-12-04 | 33 | 0 |
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 | Elekta, Inc. | 2005-08-12 | 30 | 11 |
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