FDA Product Code
FDA Product Code MUJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 257 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | 2026-07-08 | Traditional | PDF ↗ |
| K253050 | RadOncAI | Informai | 2026-06-18 | Traditional | PDF ↗ |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | 2026-05-27 | Traditional | PDF ↗ |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 2026-05-22 | Traditional | PDF ↗ |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 | Traditional | PDF ↗ |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 | Traditional | PDF ↗ |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 | Special | PDF ↗ |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 | Traditional | PDF ↗ |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 | Traditional | PDF ↗ |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 | Traditional | PDF ↗ |
| K250064 | Dose+ (1.0) | Mvision AI OY | 2025-09-04 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 | Traditional | PDF ↗ |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | 2025-04-04 | Traditional | PDF ↗ |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 | Traditional | PDF ↗ |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024-12-13 | Traditional | PDF ↗ |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024-12-11 | Traditional | PDF ↗ |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | 2024-12-04 | Traditional | PDF ↗ |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024-10-23 | Special | PDF ↗ |
| K241876 | Vitesse (5.0) | Varian Medical Systems | 2024-10-23 | Traditional | PDF ↗ |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 | Traditional | PDF ↗ |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2024-04-26 | Traditional | PDF ↗ |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024-04-22 | Traditional | PDF ↗ |
| K232479 | ART-Plan | Therapanacea | 2023-12-22 | Traditional | PDF ↗ |
| K231825 | Panther TPS | Prowess, Inc. | 2023-12-15 | Traditional | PDF ↗ |
| K232400 | VariSeed (v10) | Varian Medical Systems | 2023-09-08 | Special | PDF ↗ |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | 2023-07-10 | Traditional | PDF ↗ |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023-05-26 | Traditional | PDF ↗ |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | 2023-05-17 | Traditional | PDF ↗ |
| K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023-03-29 | Traditional | PDF ↗ |
| K223279 | RT Elements (4.0) | Brainlab AG | 2023-03-14 | Traditional | PDF ↗ |
| K223233 | Monaco RTP System | Elekta Solutions AB | 2023-02-23 | Traditional | PDF ↗ |
| K222803 | Oncospace | Oncospace, Inc. | 2023-02-02 | Traditional | PDF ↗ |
| K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2022-09-07 | Special | PDF ↗ |
| K211841 | MRI Planner | Spectronic Medical AB | 2022-08-25 | Traditional | PDF ↗ |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | 2022-08-22 | Traditional | PDF ↗ |
| K213787 | Monaco RTP System | Elekta Solutions AB | 2022-05-17 | Traditional | PDF ↗ |
| K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022-04-15 | Traditional | PDF ↗ |
| K212274 | INT Contour | Carina Medical, LLC | 2022-04-08 | Traditional | PDF ↗ |
| K214081 | MRCAT Head & Neck | Philips OY | 2022-04-05 | Traditional | PDF ↗ |
| K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory | Adaptiiv | 2022-01-19 | Traditional | PDF ↗ |
| K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021-09-08 | Traditional | PDF ↗ |
| K211881 | AI Segmentation | Varian Medical Systems, Inc. | 2021-09-02 | Traditional | PDF ↗ |
| K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K211511 | decimal Bolus | .Decimal, LLC | 2021-07-01 | Traditional | PDF ↗ |
| K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021-06-29 | Traditional | PDF ↗ |
| K211034 | Corvus Radiation Therapy Planning System | Best Nomos | 2021-05-06 | Special | PDF ↗ |
| K203469 | AI Segmentation | Varian Medical Systems, Inc. | 2021-04-19 | Traditional | PDF ↗ |
| K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review | Brainlab AG | 2021-04-09 | Traditional | PDF ↗ |
| K202284 | Oncospace | Oncospace, Inc. | 2021-03-12 | Traditional | PDF ↗ |
| K202789 | Monaco Rtp System | Elekta Solutions AB | 2021-02-23 | Traditional | PDF ↗ |
| K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2021-02-12 | Special | PDF ↗ |
| K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020-09-24 | Traditional | PDF ↗ |
| K201350 | CORVUS | Best Nomos | 2020-09-20 | Traditional | PDF ↗ |
| K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2020-08-13 | Traditional | PDF ↗ |
| K201607 | Eclipse Treatment Planning System v16.1 | Varian Medical Systems, Inc. | 2020-07-10 | Special | PDF ↗ |
| K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | 2020-06-10 | Traditional | PDF ↗ |
| K193459 | Panther Stereotactic | Prowess, Inc. | 2020-04-27 | Traditional | PDF ↗ |
| K193640 | ClearCalc | Radformation, Inc. | 2020-04-09 | Traditional | PDF ↗ |
| K200608 | Eclipse Treatment Planning System v16.0 | Varian Medical Systems, Inc. | 2020-04-03 | Special | PDF ↗ |
| K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020-01-24 | Traditional | PDF ↗ |
| K193381 | RadCalc Software | Lifeline Software, Inc. | 2019-12-31 | Special | PDF ↗ |
| K192554 | decimal3D | .Decimal, LLC | 2019-12-13 | Traditional | PDF ↗ |
| K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2019-09-18 | Traditional | PDF ↗ |
| K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | 2019-07-08 | Traditional | PDF ↗ |
| K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019-06-19 | Traditional | PDF ↗ |
| K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019-04-30 | Traditional | PDF ↗ |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | 2019-04-12 | Special | PDF ↗ |
| K190178 | Monaco RTP System | Elekta, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K182665 | Sensus TPS Workstation | Sensus Healthcare, Inc. | 2019-02-21 | Traditional | PDF ↗ |
| K183037 | Monaco RTP System | Elekta, Inc. | 2018-12-04 | Traditional | PDF ↗ |
| K180289 | 3D Bolus Software | 3D Bolus, Inc. | 2018-07-10 | Traditional | PDF ↗ |
| K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2018-05-18 | Special | PDF ↗ |
| K173940 | Astroid Planning App | .Decimal, LLC | 2018-05-15 | Traditional | PDF ↗ |
| K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018-04-25 | Traditional | PDF ↗ |
| K180308 | Prelude | Medcom GmbH | 2018-03-27 | Traditional | PDF ↗ |
| K173635 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2018-01-12 | Traditional | PDF ↗ |
| K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG | 2017-08-24 | Traditional | PDF ↗ |
| K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017-08-15 | Special | PDF ↗ |
| K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017-07-25 | Special | PDF ↗ |
| K170969 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2017-07-05 | Traditional | PDF ↗ |
| K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017-06-27 | Traditional | PDF ↗ |
| K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017-03-02 | Traditional | PDF ↗ |
| K170086 | Pinnacle Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2017-02-09 | Special | PDF ↗ |
| K162370 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2016-10-25 | Traditional | PDF ↗ |
| K161136 | Precision Treatment Planning System | Accuray Incorporated | 2016-06-24 | Traditional | PDF ↗ |
| K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016-04-08 | Traditional | PDF ↗ |
| K151435 | MRCAT | Philips Medical Systems MR Finland | 2016-02-25 | Traditional | PDF ↗ |
| K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016-02-16 | Traditional | PDF ↗ |
| K143514 | Panther StereoSeed | Prowess, Inc. | 2015-12-11 | Traditional | PDF ↗ |
| K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | 2015-11-25 | Traditional | PDF ↗ |
| K152488 | Onrad Treatment System | Accuray Incorporated | 2015-09-28 | Special | PDF ↗ |
| K152393 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2015-09-18 | Special | PDF ↗ |
| K151887 | syngo VSim | Siemens Medical Solutions USA, Inc. | 2015-09-16 | Traditional | PDF ↗ |
| K151560 | QuickPlan | Siris Medical | 2015-09-11 | Traditional | PDF ↗ |
| K151666 | Leksell GammaPlan | Elekta Instrument AB | 2015-09-03 | Traditional | PDF ↗ |
Product code MUJ · Class II · Radiology. Data: openFDA.