Stockholm, SE · 15 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IYE | — | — | — | 5 | 2026-01-15 |
| MUJ | System, Planning, Radiation Therapy Treatment | Class II | Radiology | 4 | 2026-02-19 |
| IWB | System, Radiation Therapy, Radionuclide | Class II | Radiology | 3 | 2025-07-02 |
| HAW | — | — | — | 1 | 2026-08-05 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2025-10-08 |
| QKB | Radiological Image Processing Software For Radiation Therapy | Class II | Radiology | 1 | 2021-10-25 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-09-17 | Class II | Ongoing | Z-0503-2026 | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3… | — | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended sch… |
| 2021-09-28 | Class II | Terminated | Z-0115-2022 | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta V… | — | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-05 | K261932 | Leksell® Vantage Stereotactic System | HAW | — | — |
| 2026-02-19 | K252002 | Monaco RTP System (6.3) | MUJ | Class II | Radiology |
| 2026-01-15 | K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | IYE | — | — |
| 2025-10-08 | K251363 | ProKnow DS | LLZ | Class II | Radiology |
| 2025-07-02 | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | IWB | Class II | Radiology |
| 2024-02-08 | K232854 | Leksell GammaPlan (LGP) | IWB | Class II | Radiology |
| 2023-02-23 | K223233 | Monaco RTP System | MUJ | Class II | Radiology |
| 2023-02-23 | K223229 | MOSAIQ® OIS (Oncology Information System) | IYE | — | — |
| 2023-02-23 | K223209 | Elekta Unity | IYE | — | — |
| 2022-10-26 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | IWB | Class II | Radiology |
| 2022-05-17 | K213787 | Monaco RTP System | MUJ | Class II | Radiology |
| 2021-10-25 | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | QKB | Class II | Radiology |
| 2021-10-01 | K212114 | Elekta Unity | IYE | — | — |
| 2021-02-23 | K202789 | Monaco Rtp System | MUJ | Class II | Radiology |
| 2020-12-18 | K203172 | MOSAIQ Oncology Information System | IYE | — | — |