P-Cure Proton Beam Therapy System

Q: What is the product code of K221996?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.

FDA 510(k) K221996 · P-Cure, Ltd.

Substantially Equivalent

510(k) numberK221996

Submission

Device name: P-Cure Proton Beam Therapy System
Applicant: P-Cure, Ltd.
Shilat Industrial Zone, IL
Received: July 6, 2022
Decision date: March 20, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LHN – System, Radiation Therapy, Charged-Particle, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5050
Specialty: Radiology

Other 510(k)s with product code LHN

510(k)	Device	Applicant	Decision
K260174	Probeat-CrLHN · Traditional	Hitachi High-Tech Corp.	06/11/2026SE
K252815	ProBeam 360 Proton Therapy System v3.0LHN · Traditional	Varian Medical Systems, Inc.	04/23/2026SE
K253406	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional	Mevion Medical Systems, Inc.	03/25/2026SE
K250986	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN · Traditional	Mevion Medical Systems, Inc.	09/12/2025SE
K243900	eMotus Respiratory Motion Management SystemLHN · Traditional	Empnia, Inc.	06/27/2025SE
K242418	P-Cure Proton Therapy System (PPTS)LHN · Traditional	P-Cure, Ltd.	05/12/2025SE
K232032	Probeat-FrLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	01/12/2024SE
K231863	ProBeam 360° Proton Therapy System v2.0 (Multiroom)LHN · Traditional	Varian Medical Systems, Inc.	10/06/2023SE
K220883	Small Field ApplicatorLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	12/15/2022SE
K221791	ProBeam 360° Proton Therapy SystemLHN · Traditional	Varian Medical Systems, Inc.	12/01/2022SE

More from Varian Medical Systems, Inc.

510(k)	Device	Decision
K242418	P-Cure Proton Therapy System (PPTS)LHN · Traditional	05/12/2025SE
K160611	P-ArtisJAK · Traditional	08/08/2016SE
K092424	P-Art, Model 001IYE · Traditional	03/05/2010SE

Questions and answers

When was P-Cure Proton Beam Therapy System cleared by the FDA?

P-Cure Proton Beam Therapy System (K221996) received a 510(k) decision of Substantially Equivalent on March 20, 2023, 257 days after the submission was received.

What is the product code of K221996?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.