MUJ · System, Planning, Radiation Therapy Treatment

Device class

Class II

Regulation 892.5050

Total clearances

2020-01-24 → 2026-07-08

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.5050

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Varian Medical Systems	12	2	2026-07-08
RaySearch Laboratories AB (PUBL)	9	1	2025-12-22
Siemens Medical Solutions USA, Inc.	4	0	2024-04-26
Elekta Solutions AB	4	1	2026-02-19
Therapanacea Sas	3	1	2025-12-23
Radformation, Inc.	3	1	2025-12-19
Oncospace, Inc.	3	0	2025-04-11
Brainlab AG	3	0	2025-06-17
Adaptiiv Medical Technologies, Inc.	3	1	2026-02-19
Best Nomos	2	0	2021-05-06
Prowess, Inc.	2	0	2023-12-15
Xstrahl, Ltd.	1	0	2024-12-04
Philips OY	1	0	2022-04-05
University of Texas, MD Anderson Cancer Center	1	0	2023-05-17
Cosylab Jsc, Control System Laboratory	1	1	2025-11-20
Philips Medical Systems Nederland B.V.	1	1	2026-05-27
Spectronic Medical AB	1	0	2022-08-25
Carina Medical, LLC	1	0	2022-04-08
Gmv Soluciones Globales Internet S.A.U.	1	0	2024-05-17
Manteia Technologies Co., Ltd.	1	0	2023-07-10
Informai	1	1	2026-06-18
Therapanacea	1	0	2023-12-22
Mvision AI OY	1	0	2025-09-04
Adaptiiv	1	0	2022-01-19
Philips Medical Systems MR Finland	1	0	2020-01-24

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
77290	CPT	—	High	CPT for radiation therapy treatment planning
77295	CPT	—	Medium	CPT for 3D radiation therapy planning

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-08	K260750	Varian Medical Systems, Inc.	Virtual Cone (1.0)
2026-06-18	K253050	Informai	RadOncAI
2026-05-27	K260207	Philips Medical Systems Nederland B.V.	Multimodality Simulation Workspace (MM Sim) (v1.0.0)
2026-05-22	K252784	Anatomical Geometry S.L.	eXaSkin Plus
2026-05-14	K253078	Seetreat Pty, Ltd.	ART.1-US
2026-03-18	K252304	Varian Medical Systems, Inc.	syngo.via RT Image Suite VC10
2026-02-19	K260308	Adaptiiv Medical Technologies, Inc.	TrueFit Bolus
2026-02-19	K252002	Elekta Solutions AB	Monaco RTP System (6.3)
2025-12-23	K253091	Therapanacea Sas	ART-Plan+ (v3.1.0)
2025-12-22	K252109	RaySearch Laboratories AB (PUBL)	RayStation (2024A SP3)
2025-12-19	K252863	Radformation, Inc.	ClearCalc Model RADCA V2.6
2025-11-20	K250963	Cosylab Jsc, Control System Laboratory	PlanOne 1
2025-09-04	K250064	Mvision AI OY	Dose+ (1.0)
2025-06-17	K250440	Brainlab AG	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
2025-04-17	K242992	RaySearch Laboratories AB (PUBL)	RayCare (2024A SP1)
2025-04-11	K242748	Oncospace, Inc.	Oncospace
2025-04-04	K240398	RaySearch Laboratories AB (PUBL)	RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
2025-02-25	K242822	Therapanacea Sas	ART-Plan+ (v.3.0.0)
2024-12-13	K242463	Varian Medical Systems, Inc.	ARIA Radiation Therapy Management System (18.1)
2024-12-11	K242378	Varian Medical Systems	Eclipse Treatment Planning System (18.1)
2024-12-04	K240671	Xstrahl, Ltd.	XBeam (v2)
2024-10-23	K243057	Adaptiiv Medical Technologies, Inc.	TrueFit Bolus; TrueFlex Bolus
2024-10-23	K241876	Varian Medical Systems	Vitesse (5.0)
2024-08-30	K241318	Adaptiiv Medical Technologies, Inc.	Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
2024-05-17	K233236	Gmv Soluciones Globales Internet S.A.U.	Radiance V5