LHN · Class II · 21 CFR 892.5050

FDA Product Code LHN: System, Radiation Therapy, Charged-particle, Medical

Leading manufacturers include Ion Beam Applications S.A., Varian Medical Systems, Inc. and Hitachi, Ltd., Health Care Company.

93
Total
93
Cleared
143d
Avg days
1985
Since
Growing category - 7 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 198d recently vs 138d historically

FDA 510(k) Cleared System, Radiation Therapy, Charged-particle, Medical Devices (Product Code LHN)

93 devices
1–24 of 93
Cleared Sep 23, 2026
VIRTUE QA
K260597
ProNova Solutions
Radiology · 211d
Cleared Jun 11, 2026
PROBEAT-CR
K260174
Hitachi High-Tech Corp.
Radiology · 141d
Cleared Apr 23, 2026
ProBeam 360 Proton Therapy System v3.0
K252815
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Mar 25, 2026
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K253406
Mevion Medical Systems, Inc.
Radiology · 176d
Cleared Sep 12, 2025
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
K250986
Mevion Medical Systems, Inc.
Radiology · 165d
Cleared Jun 27, 2025
eMotus Respiratory Motion Management System
K243900
Empnia, Inc.
Radiology · 190d
Cleared May 12, 2025
P-Cure Proton Therapy System (PPTS)
K242418
P-Cure, Ltd.
Radiology · 270d
Cleared Jan 12, 2024
PROBEAT-FR
K232032
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Radiology · 189d
Cleared Oct 06, 2023
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
K231863
Varian Medical Systems, Inc.
Radiology · 105d
Cleared Mar 20, 2023
P-Cure Proton Beam Therapy System
K221996
P-Cure, Ltd.
Radiology · 257d
Cleared Dec 15, 2022
Small Field Applicator
K220883
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Radiology · 265d
Cleared Dec 01, 2022
ProBeam 360° Proton Therapy System
K221791
Varian Medical Systems, Inc.
Radiology · 163d
Cleared Jul 17, 2020
myQA iON
K201798
Iba Dosimetry GmbH
Radiology · 17d
Cleared Jul 13, 2020
PROBEAT-CR
K201042
Hitachi , Ltd.
Radiology · 84d
Cleared Apr 08, 2020
Orfit Aerial Couchtop
K200282
Orfit Industries NV
Radiology · 64d
Cleared Jan 23, 2020
Blue Phantom PT
K191821
Iba Dosimetry GmbH
Radiology · 199d
Cleared Sep 27, 2019
Radiance 330 Proton Beam Therapy System
K191521
Protom International Holding Corporation
Radiology · 112d
Cleared Sep 13, 2019
PROBEAT-CR
K191801
Hitachi , Ltd.
Radiology · 72d
Cleared Dec 10, 2018
X-ray Imaging System for the McLaren Proton Treatment System
K181498
Ehmetdx, LLC
Radiology · 186d
Cleared Sep 21, 2018
VeriSuite
K181789
Medcom GmbH
Radiology · 78d
Cleared Aug 15, 2018
Mini Ridge Filter and auxiliary functions for PROBEAT-V
K181676
Hitachi Ltd. Healthcare Hitachi Works
Radiology · 51d
Cleared Dec 27, 2017
MEVION S250i Proton Beam Radiation Therapy Device
K172848
Mevion Medical Systems
Radiology · 99d
Cleared Dec 26, 2017
Real Time Image Gating System for Proton Beam Therapy Systems
K171049
Hitachi, Ltd. Healthcare
Radiology · 263d
Cleared Aug 17, 2017
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
K163500
Ion Beam Applications S.A.
Radiology · 247d

About Product Code LHN - Regulatory Context

510(k) Submission Activity

93 total 510(k) submissions under product code LHN since 1985, with 93 receiving FDA clearance (average review time: 143 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LHN Product Code

Recent submissions under LHN have taken an average of 198 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.

LHN devices are reviewed by the Radiology panel. Browse all Radiology devices →