Probeat-Cr

Q: When was Probeat-Cr cleared by the FDA?

Probeat-Cr (K201042) received a 510(k) decision of Substantially Equivalent on July 13, 2020, 84 days after the submission was received.

Q: What is the product code of K201042?

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) K201042 · Hitachi , Ltd.

Substantially Equivalent

510(k) numberK201042

Submission

Device name: Probeat-Cr
Applicant: Hitachi , Ltd.
Kashiwa-Shi, JP
Received: April 20, 2020
Decision date: July 13, 2020
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
K221996	P-Cure Proton Beam Therapy SystemLHN · Traditional	P-Cure, Ltd.	03/20/2023SE
K220883	Small Field ApplicatorLHN · Traditional	Hitachi, Ltd. Radiation Oncology Systems…	12/15/2022SE

More from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

510(k)	Device	Decision
K191801	Probeat-CrLHN · Traditional	09/13/2019SE
K172087	SangrayMOT · Traditional	10/27/2017SE
K163505	Arietta PrecisionIYN · Traditional	05/30/2017SE
K162902	ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYN · Traditional	12/15/2016SE
K162583	Aloka Lisendo 880IYN · Traditional	11/17/2016SE
K161163	PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryLHN · Traditional	07/13/2016SE
K060834	Probeat with MGCSLHN · Special	04/19/2006SE

Questions and answers

When was Probeat-Cr cleared by the FDA?

Probeat-Cr (K201042) received a 510(k) decision of Substantially Equivalent on July 13, 2020, 84 days after the submission was received.

What is the product code of K201042?

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