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| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| K250064 | Dose+ (1.0) | Mvision AI OY | 2025-09-04 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | 2025-06-17 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 |