| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta | December 14, 2025 |
| Z-1339-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ver | December 12, 2025 |
| Z-1340-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ver | December 12, 2025 |
| Z-1078-2026 | Class II | MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) | December 10, 2025 |
| Z-0433-2026 | Class II | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software | September 30, 2025 |
| Z-1162-2025 | Class II | MOSAIQ Oncology Information System | January 15, 2025 |
| Z-0444-2024 | Class II | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation T | October 25, 2023 |
| Z-0446-2024 | Class II | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle | October 25, 2023 |
| Z-0443-2024 | Class II | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sy | October 25, 2023 |
| Z-0445-2024 | Class II | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accel | October 25, 2023 |
| Z-0447-2024 | Class II | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerat | October 25, 2023 |
| Z-0442-2024 | Class II | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiati | October 25, 2023 |
| Z-1665-2023 | Class II | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; | May 5, 2023 |
| Z-1675-2023 | Class II | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | April 6, 2023 |
| Z-1233-2023 | Class II | Monaco RTP System. Used to make treatment plans for patients with prescriptions for external be | February 28, 2023 |
| Z-0719-2023 | Class II | Oncentra Brachy radiation therapy planning system software. | December 5, 2022 |
| Z-0182-2022 | Class II | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 | October 13, 2021 |
| Z-0116-2022 | Class II | Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accele | September 17, 2021 |
| Z-2563-2021 | Class II | Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for exte | September 14, 2021 |
| Z-2591-2021 | Class II | MOSAIQ Oncology Information System | September 2, 2021 |