Elekta Solutions AB
Medical device manufacturer in Stockholm, SE.
15510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | 08/05/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | 02/19/2026SE |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…IYE · Traditional | 01/15/2026SE |
| K251363 | ProKnow DSLLZ · Traditional | 10/08/2025SE |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife®…IWB · Traditional | 07/02/2025SE |
| K232854 | Leksell GammaPlan (LGP)IWB · Traditional | 02/08/2024SE |
| K223233 | Monaco RTP SystemMUJ · Traditional | 02/23/2023SE |
| K223229 | MOSAIQ® OIS (Oncology Information System)IYE · Traditional | 02/23/2023SE |
| K223209 | Elekta UnityIYE · Traditional | 02/23/2023SE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…IWB · Traditional | 10/26/2022SE |
| K213787 | Monaco RTP SystemMUJ · Traditional | 05/17/2022SE |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA)QKB · Traditional | 10/25/2021SE |
| K212114 | Elekta UnityIYE · Traditional | 10/01/2021SE |
| K202789 | Monaco Rtp SystemMUJ · Traditional | 02/23/2021SE |
| K203172 | MOSAIQ Oncology Information SystemIYE · Traditional | 12/18/2020SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0503-2026 Class II | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0…When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of… | 09/17/2025Open, Classified |
| Z-0115-2022 Class II | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta…There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the… | 09/28/2021Terminated |