| Virtual Cone (1.0) (K260750) | Varian Medical Systems, Inc. | 2026-07-08 |
| RadOncAI (K253050) | Informai | 2026-06-18 |
| Multimodality Simulation Workspace (MM Sim) (v1.0.0) (K260207) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| eXaSkin Plus (K252784) | Anatomical Geometry S.L. | 2026-05-22 |
| ART.1-US (K253078) | Seetreat Pty, Ltd. | 2026-05-14 |
| syngo.via RT Image Suite VC10 (K252304) | Varian Medical Systems, Inc. | 2026-03-18 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
| ART-Plan+ (v3.1.0) (K253091) | Therapanacea Sas | 2025-12-23 |
| RayStation (2024A SP3) (K252109) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| ClearCalc Model RADCA V2.6 (K252863) | Radformation, Inc. | 2025-12-19 |
| PlanOne 1 (K250963) | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| Dose+ (1.0) (K250064) | Mvision AI OY | 2025-09-04 |
| 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 (K250440) | Brainlab AG | 2025-06-17 |
| RayCare (2024A SP1) (K242992) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| Oncospace (K242748) | Oncospace, Inc. | 2025-04-11 |
| RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (K240398) | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
| ART-Plan+ (v.3.0.0) (K242822) | Therapanacea Sas | 2025-02-25 |
| ARIA Radiation Therapy Management System (18.1) (K242463) | Varian Medical Systems, Inc. | 2024-12-13 |
| Eclipse Treatment Planning System (18.1) (K242378) | Varian Medical Systems | 2024-12-11 |
| XBeam (v2) (K240671) | Xstrahl, Ltd. | 2024-12-04 |
| Vitesse (5.0) (K241876) | Varian Medical Systems | 2024-10-23 |
| TrueFit Bolus; TrueFlex Bolus (K243057) | Adaptiiv Medical Technologies, Inc. | 2024-10-23 |
| Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) (K241318) | Adaptiiv Medical Technologies, Inc. | 2024-08-30 |
| Radiance V5 (K233236) | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 |
| syngo.via RT Image Suite (K232799) | Siemens Medical Solutions USA, Inc. | 2024-04-26 |
| ART-Plan (v.2.2.0) (K234068) | Therapanacea Sas | 2024-04-22 |
| ART-Plan (K232479) | Therapanacea | 2023-12-22 |
| Panther TPS (K231825) | Prowess, Inc. | 2023-12-15 |
| VariSeed (v10) (K232400) | Varian Medical Systems | 2023-09-08 |
| MOZI TPS (K223724) | Manteia Technologies Co., Ltd. | 2023-07-10 |
| Eclipse Treatment Planning System (v18.0) (K230557) | Varian Medical Systems, Inc. | 2023-05-26 |
| Radiation Planning Assistant (RPA) (K222728) | University of Texas, MD Anderson Cancer Center | 2023-05-17 |
| RayStation 12A (K222312) | RaySearch Laboratories AB (PUBL) | 2023-03-29 |
| RT Elements (4.0) (K223279) | Brainlab AG | 2023-03-14 |
| Monaco RTP System (K223233) | Elekta Solutions AB | 2023-02-23 |
| Oncospace (K222803) | Oncospace, Inc. | 2023-02-02 |
| syngo.via RT Image Suite (K220783) | Siemens Medical Solutions USA, Inc. | 2022-09-07 |
| MRI Planner (K211841) | Spectronic Medical AB | 2022-08-25 |
| ClearCalc Model RADCA V2 (K220582) | Radformation, Inc. | 2022-08-22 |
| Monaco RTP System (K213787) | Elekta Solutions AB | 2022-05-17 |
| RayStation 11B (K220141) | RaySearch Laboratories AB (PUBL) | 2022-04-15 |
| INT Contour (K212274) | Carina Medical, LLC | 2022-04-08 |
| MRCAT Head & Neck (K214081) | Philips OY | 2022-04-05 |
| 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory (K213438) | Adaptiiv | 2022-01-19 |
| RayStation 11.0 (K211867) | RaySearch Laboratories AB (PUBL) | 2021-09-08 |
| AI Segmentation (K211881) | Varian Medical Systems, Inc. | 2021-09-02 |
| syngo.via RT Image Suite (K211379) | Siemens Medical Solutions USA, Inc. | 2021-07-30 |
| decimal Bolus (K211511) | .Decimal, LLC | 2021-07-01 |
| RayStation 10.1 (K210645) | RaySearch Laboratories AB (PUBL) | 2021-06-29 |
| Corvus Radiation Therapy Planning System (K211034) | Best Nomos | 2021-05-06 |
| AI Segmentation (K203469) | Varian Medical Systems, Inc. | 2021-04-19 |
| RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681) | Brainlab AG | 2021-04-09 |
| Oncospace (K202284) | Oncospace, Inc. | 2021-03-12 |
| Monaco Rtp System (K202789) | Elekta Solutions AB | 2021-02-23 |
| 4D Integrated Treatment Console (K203766) | Varian Medical Systems, Inc. | 2021-02-12 |
| RayStation (K200569) | RaySearch Laboratories AB (PUBL) | 2020-09-24 |
| CORVUS (K201350) | Best Nomos | 2020-09-20 |
| Syngo.via RT Image Suite (K201444) | Siemens Medical Solutions USA, Inc. | 2020-08-13 |
| Eclipse Treatment Planning System v16.1 (K201607) | Varian Medical Systems, Inc. | 2020-07-10 |
| RayCare 3.1 (K200487) | RaySearch Laboratories AB (PUBL) | 2020-06-10 |
| Panther Stereotactic (K193459) | Prowess, Inc. | 2020-04-27 |
| ClearCalc (K193640) | Radformation, Inc. | 2020-04-09 |
| Eclipse Treatment Planning System v16.0 (K200608) | Varian Medical Systems, Inc. | 2020-04-03 |
| MRCAT brain (K193109) | Philips Medical Systems MR Finland | 2020-01-24 |
| RadCalc Software (K193381) | Lifeline Software, Inc. | 2019-12-31 |
| decimal3D (K192554) | .Decimal, LLC | 2019-12-13 |
| Syngo.Via RT Image Suite (K192065) | Siemens Medical Solutions USA, Inc. | 2019-09-18 |
| RayCare 2.3 (K191384) | RaySearch Laboratories AB (PUBL) | 2019-07-08 |
| RayStation (K190387) | RaySearch Laboratories AB (PUBL) | 2019-06-19 |
| MRCAT Pelvis (K182888) | Philips Medical Systems MR Finland | 2019-04-30 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K190664) | Brainlab AG | 2019-04-12 |
| Monaco RTP System (K190178) | Elekta, Inc. | 2019-03-29 |
| Sensus TPS Workstation (K182665) | Sensus Healthcare, Inc. | 2019-02-21 |
| Monaco RTP System (K183037) | Elekta, Inc. | 2018-12-04 |
| 3D Bolus Software (K180289) | 3D Bolus, Inc. | 2018-07-10 |
| Eclipse Treatment Planning System (K181145) | Varian Medical Systems, Inc. | 2018-05-18 |
| Astroid Planning App (K173940) | .Decimal, LLC | 2018-05-15 |
| RayStation 7 (K180379) | RaySearch Laboratories AB (PUBL) | 2018-04-25 |
| Prelude (K180308) | Medcom GmbH | 2018-03-27 |
| syngo.via RT Image Suite (K173635) | Siemens Medical Solutions USA, Inc. | 2018-01-12 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K170750) | Brainlab AG | 2017-08-24 |
| Eclipse Treatment Planning System (K172163) | Varian Medical Systems, Inc. | 2017-08-15 |
| Radiance V4 (K171885) | Gmv Soluciones Globales Internet S.A.U. | 2017-07-25 |
| Eclipse Treatment Planning System (K170969) | Varian Medical Systems, Inc. | 2017-07-05 |
| RayStation (K171536) | RaySearch Laboratories AB (PUBL) | 2017-06-27 |
| RayStation 6 (K170355) | RaySearch Laboratories AB (PUBL) | 2017-03-02 |
| Pinnacle Radiation Therapy Planning System (K170086) | Philips Medical Systems (Cleveland), Inc. | 2017-02-09 |
| syngo.via RT Image Suite (K162370) | Siemens Medical Solutions USA, Inc. | 2016-10-25 |
| Precision Treatment Planning System (K161136) | Accuray Incorporated | 2016-06-24 |
| RayStation (K160093) | RaySearch Laboratories AB (PUBL) | 2016-04-08 |
| MRCAT (K151435) | Philips Medical Systems MR Finland | 2016-02-25 |
| Radiance V3 (K153368) | Gmv Soluciones Globales Internet S.A.U. | 2016-02-16 |
| Panther StereoSeed (K143514) | Prowess, Inc. | 2015-12-11 |
| CORVUS Radiation Therapy Planning System (K151469) | Best Nomos | 2015-11-25 |
| Onrad Treatment System (K152488) | Accuray Incorporated | 2015-09-28 |
| Eclipse Treatment Planning System (K152393) | Varian Medical Systems, Inc. | 2015-09-18 |
| syngo VSim (K151887) | Siemens Medical Solutions USA, Inc. | 2015-09-16 |
| QuickPlan (K151560) | Siris Medical | 2015-09-11 |
| Leksell GammaPlan (K151666) | Elekta Instrument AB | 2015-09-03 |