Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekta Solutions AB — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
185 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | 2026-08-05 | 57 | 0 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 | 237 | 0 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro) | Elekta Solutions AB | 2026-01-15 | 185 | 0 |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 | 160 | 0 |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® ( | Elekta Solutions AB | 2025-07-02 | 140 | 1 |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024-02-08 | 146 | 0 |
| K223209 | Elekta Unity | Elekta Solutions AB | 2023-02-23 | 129 | 0 |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | 2023-02-23 | 128 | 4 |
| K223233 | Monaco RTP System | Elekta Solutions AB | 2023-02-23 | 127 | 0 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Lek | Elekta Solutions AB | 2022-10-26 | 106 | 0 |
| K213787 | Monaco RTP System | Elekta Solutions AB | 2022-05-17 | 162 | 0 |
| K212218 | Advanced Algorithms for Treatment Management Applications (A | Elekta Solutions AB | 2021-10-25 | 101 | 0 |
| K212114 | Elekta Unity | Elekta Solutions AB | 2021-10-01 | 86 | 1 |
| K202789 | Monaco Rtp System | Elekta Solutions AB | 2021-02-23 | 154 | 0 |
| K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020-12-18 | 53 | 1 |
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