Product Code: LHN FDA class 2 21 CFR 892.5050

System, Radiation Therapy, Charged-Particle, Medical

Radiology

A charged-particle medical radiation therapy system is a radiotherapy device that uses beams of charged particles such as protons or carbon ions to deliver targeted radiation doses to tumors, allowing more precise dose deposition and reduced exposure to surrounding healthy tissue compared to conventional photon-based radiotherapy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LHN and is regulated under 21 CFR 892.5050 within the Radiology specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LHN in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LHN
Device Class: FDA class 2
Regulation Number: 892.5050
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 92 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260174	PROBEAT-CR	Jun 11, 2026	Substantially Equivalent	Hitachi High-Tech Corp.
K252815	ProBeam 360 Proton Therapy System v3.0	Apr 23, 2026	Substantially Equivalent	Varian Medical Systems, Inc.
K253406	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	Mar 25, 2026	Substantially Equivalent	Mevion Medical Systems, Inc.
K250986	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	Sep 12, 2025	Substantially Equivalent	Mevion Medical Systems, Inc.
K243900	eMotus Respiratory Motion Management System	Jun 27, 2025	Substantially Equivalent	Empnia, Inc.
K242418	P-Cure Proton Therapy System (PPTS)	May 12, 2025	Substantially Equivalent	P-Cure, Ltd.
K232032	PROBEAT-FR	Jan 12, 2024	Substantially Equivalent	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
K231863	ProBeam 360° Proton Therapy System v2.0 (Multiroom)	Oct 06, 2023	Substantially Equivalent	Varian Medical Systems, Inc.
K221996	P-Cure Proton Beam Therapy System	Mar 20, 2023	Substantially Equivalent	P-Cure, Ltd.
K220883	Small Field Applicator	Dec 15, 2022	Substantially Equivalent	Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
K221791	ProBeam 360° Proton Therapy System	Dec 01, 2022	Substantially Equivalent	Varian Medical Systems, Inc.
K201798	myQA iON	Jul 17, 2020	Substantially Equivalent	Iba Dosimetry GmbH
K201042	PROBEAT-CR	Jul 13, 2020	Substantially Equivalent	Hitachi , Ltd.
K200282	Orfit Aerial Couchtop	Apr 08, 2020	Substantially Equivalent	Orfit Industries NV
K191821	Blue Phantom PT	Jan 23, 2020	Substantially Equivalent	Iba Dosimetry GmbH
K191521	Radiance 330 Proton Beam Therapy System	Sep 27, 2019	Substantially Equivalent	Protom International Holding Corporation
K191801	PROBEAT-CR	Sep 13, 2019	Substantially Equivalent	Hitachi , Ltd.
K181498	X-ray Imaging System for the McLaren Proton Treatment System	Dec 10, 2018	Substantially Equivalent	Ehmetdx, LLC
K181789	VeriSuite	Sep 21, 2018	Substantially Equivalent	Medcom GmbH
K181676	Mini Ridge Filter and auxiliary functions for PROBEAT-V	Aug 15, 2018	Substantially Equivalent	Hitachi Ltd. Healthcare Hitachi Works
K172848	MEVION S250i Proton Beam Radiation Therapy Device	Dec 27, 2017	Substantially Equivalent	Mevion Medical Systems
K171049	Real Time Image Gating System for Proton Beam Therapy Systems	Dec 26, 2017	Substantially Equivalent	Hitachi, Ltd. Healthcare
K163500	IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)	Aug 17, 2017	Substantially Equivalent	Ion Beam Applications S.A.
K170719	Anzai Respiratory Gating System	Apr 05, 2017	Substantially Equivalent	Anzai Medical Co., Ltd.
K162246	ProNova SC360 Proton Therapy System	Dec 08, 2016	Substantially Equivalent	Pronova Solutions, LLC
K160612	Sumitomo Proton Therapy System	Aug 17, 2016	Substantially Equivalent	Sumitomo Heavy Industries, Ltd.
K152224	Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)	Aug 09, 2016	Substantially Equivalent	Ion Beam Application S.A.
K161163	PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory	Jul 13, 2016	Substantially Equivalent	Hitachi , Ltd.
K160432	Anzai Respiratory Gating System	Apr 22, 2016	Substantially Equivalent	Anzai Medical Co., Ltd.
K153614	PROBEAT-V and accessories	Apr 21, 2016	Substantially Equivalent	Hitachi, Ltd., Health Care Company
K160063	McLaren Proton Therapy System	Feb 25, 2016	Substantially Equivalent	Mclaren Health Care Corporation
K152592	PROBEAT-V	Nov 02, 2015	Substantially Equivalent	Hitachi, Ltd., Health Care Company
K152207	Extended Range Shifter for PROBEAT-V	Oct 02, 2015	Substantially Equivalent	Hitachi, Ltd., Health Care Company
K151132	PROBEAT-V	Jun 01, 2015	Substantially Equivalent	Hitachi, Ltd., Health Care Company
K132919	GANTRY BEAM LINE	Jul 10, 2014	Substantially Equivalent	Ion Beam Applications S.A.
K133914	VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE	Apr 03, 2014	Substantially Equivalent	Medcom GmbH
K134052	RADIANCE 330 PROTON THERAPY SYSTEM	Mar 14, 2014	Substantially Equivalent	Protom International, Inc.
K133191	PROBEAM PROTON THERAPY SYSTEM	Jan 10, 2014	Substantially Equivalent	Varian Medical Systems
K132847	I2C	Nov 20, 2013	Substantially Equivalent	Ion Beam Applications S.A.
K130426	SUMITOMO PROTON THERAPY SYSTEM	Nov 19, 2013	Substantially Equivalent	Sumitomo Heavy Industries, Ltd.
K124002	VERIFICATION CONSOLE	Feb 21, 2013	Substantially Equivalent	Varian Medical Systems
K120676	S-250 PROTON BEAM RADIATION THERAPY SYSTEM	Jun 04, 2012	Substantially Equivalent	Mevion Medical Systems
K112969	AIR-BAG SYSTEM	Mar 14, 2012	Substantially Equivalent	Niigata Mechatronics Co., Ltd.
K112981	SUN 125C IONIZATION CHAMBER	Jan 25, 2012	Substantially Equivalent	Sun Nuclear Corp.
K112768	CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING	Nov 18, 2011	Substantially Equivalent	Calypso Medical Technologies, Inc.
K101294	PT2 VARIAN PROTON THERAPY SYSTEM	Dec 27, 2010	Substantially Equivalent	Varian Medical Systems, Oncology Systems
K102373	CALYPSO SYSTEM WITH DYNAMIC EDGE GATING	Sep 30, 2010	Substantially Equivalent	Calypso Medical Technologies, Inc.
K101508	MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235	Aug 06, 2010	Substantially Equivalent	Ion Beam Applications S.A.
K100766	IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235	Jul 21, 2010	Substantially Equivalent	Ion Beam Applications S.A.
K093250	PROTON THERAPY MULTILEAF COLLIMATOR	Dec 24, 2009	Substantially Equivalent	Varian Medical Systems
K092796	IBA PROTON THERAPY SYSTEM, PROTEUS 235	Dec 22, 2009	Substantially Equivalent	Ion Beam Applications S.A.
K092653	VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8	Sep 18, 2009	Substantially Equivalent	Medcom GmbH
K091629	PROTEUS 235 PROTON THERAPY SYSTEM	Aug 11, 2009	Substantially Equivalent	Ion Beam Applications S.A.
K083058	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Apr 15, 2009	Substantially Equivalent	Ion Beam Applications S.A.
K082416	IBA PROTON THERAPY SYSTEM- PROTEUS 235	Dec 12, 2008	Substantially Equivalent	Ion Beam Applications S.A.
K080799	ATLAS-BASED AUTOSEGMENTATION	Aug 07, 2008	Substantially Equivalent	Computerized Medical Systems, Inc.
K080886	IPLAN RT IMAGE	Jun 24, 2008	Substantially Equivalent	Brainlab AG
K073059	PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM	Dec 10, 2007	Substantially Equivalent	Hitachi, Ltd., Power Systems Group
K071399	DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100	Jun 20, 2007	Substantially Equivalent	Sicel Technologies, Inc.
K062891	PROTON THERAPY SYSTEM	Dec 14, 2006	Substantially Equivalent	Indiana University Cyclotron Facility
K061913	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Jul 28, 2006	Substantially Equivalent	Ion Beam Applications S.A.
K061051	DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER	Jun 13, 2006	Substantially Equivalent	Sicel Technologies, Inc.
K061152	MUCHECK V7.0	May 10, 2006	Substantially Equivalent	Oncology Data Systems, Inc.
K060834	PROBEAT WITH MGCS	Apr 19, 2006	Substantially Equivalent	Hitachi , Ltd.
K060695	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Apr 11, 2006	Substantially Equivalent	Ion Beam Applications S.A.
K052118	DOSE VERIFICATION SYSTEM	Apr 03, 2006	Substantially Equivalent	Sicel Technologies, Inc.
K053280	PROBEAT	Mar 09, 2006	Substantially Equivalent	Hitachi, Ltd., Power Systems Group
K053641	IBA PROTON THERAPY SYSTEM-PROTEUS 235	Jan 24, 2006	Substantially Equivalent	Ion Beam Applications S.A.
K032511	INTUITION IMAGE	Jan 21, 2004	Substantially Equivalent	Brainlab AG
K032886	DIAMOND SETUP 2000	Jan 09, 2004	Substantially Equivalent	K&S Assoc., Inc.
K031385	ANZAI AZ-733 RESPIRATORY GATING SYSTEM	Nov 10, 2003	Substantially Equivalent	Anzai Medical Co., Ltd.
K983332	NORTHEAST PROTON THERAPY CENTER	Jul 20, 2001	Substantially Equivalent	Massachusetts General Hospital
K983024	PROTON THERAPY SYSTEM	Jul 12, 2001	Substantially Equivalent	Ion Beam Applications S.A.
K002194	TREATVISION	Aug 18, 2000	Substantially Equivalent	Varian Medical Systems, Inc.
K992414	PROTON BEAM THERAPY SYSTEM (PBTS)	Jul 21, 2000	Substantially Equivalent	Optivus Technology, Inc.
K983660	EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)	Jul 14, 1999	Substantially Equivalent	Brainlab, Inc.
K983629	RPM RESPIRATORY GATING SYSTEM	Jun 08, 1999	Substantially Equivalent	Varian Medical Systems, Inc.
K982952	IMFAST	Mar 05, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K983342	MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE	Dec 21, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K982937	MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER	Nov 19, 1998	Substantially Equivalent	Victoreen, Inc.
K981112	MOBETRON	Jul 24, 1998	Substantially Equivalent	Intraop Medical, Inc.
K981358	ARTOSCAN S	Jul 13, 1998	Substantially Equivalent	Biosound Esaote, Inc.
K981115	RADIO-PLAST	Jun 25, 1998	Substantially Equivalent	Smith & Nephew, Inc.
K973960	MODEL 37-185	Jan 14, 1998	Substantially Equivalent	Victoreen, Inc.
K972212	0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER	Sep 10, 1997	Substantially Equivalent	Ptw-New York Corp.
K972211	MULTIDOS, QC6PLUS	Sep 10, 1997	Substantially Equivalent	Ptw-New York Corp.
K953391	TREATMENT MANAGEMENT SYSTEM	Mar 07, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K891261	INTRAOPERATIVE RADIATION THERAPY DEVICES	Apr 26, 1989	Substantially Equivalent	General Electric Co.
K860606	RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM	Mar 20, 1986	Substantially Equivalent	Bionix Corp.
K853964	COMPUTERIZED RADIATION TREATMENT PLANNING SYS	Dec 05, 1985	Substantially Equivalent	Computerized Medical Systems, Inc.
K851301	TARGET CAT#B7850AA & B7850AB & B7850B	Sep 20, 1985	Substantially Equivalent	General Electric Co.
K852907	SIEMENS MEVATRON ME	Sep 19, 1985	Substantially Equivalent	Siemens Medical Laboratories, Inc.