Elekta Solutions AB
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories5
Latest Approval2026-02-19
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252002 | Monaco RTP System (6.3) | MUJ | 2026-02-19 | View |
| 510(k) | K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | IYE | 2026-01-15 | View |
| 510(k) | K251363 | ProKnow DS | LLZ | 2025-10-08 | View |
| 510(k) | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | IWB | 2025-07-02 | View |
| 510(k) | K232854 | Leksell GammaPlan (LGP) | IWB | 2024-02-08 | View |
| 510(k) | K223233 | Monaco RTP System | MUJ | 2023-02-23 | View |
| 510(k) | K223209 | Elekta Unity | IYE | 2023-02-23 | View |
| 510(k) | K223229 | MOSAIQ® OIS (Oncology Information System) | IYE | 2023-02-23 | View |
| 510(k) | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | IWB | 2022-10-26 | View |
| 510(k) | K213787 | Monaco RTP System | MUJ | 2022-05-17 | View |
| 510(k) | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | QKB | 2021-10-25 | View |
| 510(k) | K212114 | Elekta Unity | IYE | 2021-10-01 | View |
| 510(k) | K202789 | Monaco Rtp System | MUJ | 2021-02-23 | View |
| 510(k) | K203172 | MOSAIQ Oncology Information System | IYE | 2020-12-18 | View |
No matching devices.