LHN · System, Radiation Therapy, Charged-Particle, Medical

Device class

Class II

Regulation 892.5050

Total clearances

2020-01-23 → 2026-06-11

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, Inc.	3	1	2026-04-23
Mevion Medical Systems, Inc.	2	2	2026-03-25
Iba Dosimetry GmbH	2	0	2020-07-17
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha	2	0	2024-01-12
P-Cure, Ltd.	2	0	2025-05-12
Hitachi , Ltd.	1	0	2020-07-13
Orfit Industries NV	1	0	2020-04-08
Hitachi High-Tech Corp.	1	1	2026-06-11
Empnia, Inc.	1	0	2025-06-27

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
77523	CPT	—	High	CPT code for intensity-modulated radiation therapy (IMRT) planning and delivery with charged particles
77799	CPT	—	Medium	Unlisted radiation oncology procedure code for specialized particle therapy systems

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-11	K260174	Hitachi High-Tech Corp.	PROBEAT-CR
2026-04-23	K252815	Varian Medical Systems, Inc.	ProBeam 360 Proton Therapy System v3.0
2026-03-25	K253406	Mevion Medical Systems, Inc.	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
2025-09-12	K250986	Mevion Medical Systems, Inc.	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
2025-06-27	K243900	Empnia, Inc.	eMotus Respiratory Motion Management System
2025-05-12	K242418	P-Cure, Ltd.	P-Cure Proton Therapy System (PPTS)
2024-01-12	K232032	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha	PROBEAT-FR
2023-10-06	K231863	Varian Medical Systems, Inc.	ProBeam 360° Proton Therapy System v2.0 (Multiroom)
2023-03-20	K221996	P-Cure, Ltd.	P-Cure Proton Beam Therapy System
2022-12-15	K220883	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha	Small Field Applicator
2022-12-01	K221791	Varian Medical Systems, Inc.	ProBeam 360° Proton Therapy System
2020-07-17	K201798	Iba Dosimetry GmbH	myQA iON
2020-07-13	K201042	Hitachi , Ltd.	PROBEAT-CR
2020-04-08	K200282	Orfit Industries NV	Orfit Aerial Couchtop
2020-01-23	K191821	Iba Dosimetry GmbH	Blue Phantom PT