ELEKTA SOLUTIONS AB
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0503-2026 | Class II | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Versi | September 17, 2025 |
| Z-0115-2022 | Class II | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1 | September 28, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252002 | Monaco RTP System (6.3) | February 19, 2026 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta H | January 15, 2026 |
| K251363 | ProKnow DS | October 8, 2025 |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion | July 2, 2025 |
| K232854 | Leksell GammaPlan (LGP) | February 8, 2024 |
| K223229 | MOSAIQ® OIS (Oncology Information System) | February 23, 2023 |
| K223209 | Elekta Unity | February 23, 2023 |
| K223233 | Monaco RTP System | February 23, 2023 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New mo | October 26, 2022 |
| K213787 | Monaco RTP System | May 17, 2022 |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | October 25, 2021 |
| K212114 | Elekta Unity | October 1, 2021 |
| K202789 | Monaco Rtp System | February 23, 2021 |
| K203172 | MOSAIQ Oncology Information System | December 18, 2020 |