LHN · Class II · 21 CFR 892.5050

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

Leading manufacturers include Varian Medical Systems, Inc., Hitachi , Ltd. and Iba Dosimetry GmbH.

92
Total
92
Cleared
142d
Avg days
1985
Since
Stable submission activity - 6 submissions in the last 2 years
Review times increasing: avg 196d recently vs 138d historically

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

92 devices
1–24 of 92
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 Jun 24, 2008
IPLAN RT IMAGE
K080886
Brainlab AG
Radiology · 85d
Cleared Jan 21, 2004
INTUITION IMAGE
K032511
Brainlab AG
Radiology · 160d
Cleared Aug 18, 2000
TREATVISION
K002194
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jun 08, 1999
RPM RESPIRATORY GATING SYSTEM
K983629
Varian Medical Systems, Inc.
Radiology · 236d
Cleared Mar 05, 1999
IMFAST
K982952
Siemens Medical Solutions USA, Inc.
Radiology · 193d

About Product Code LHN - Regulatory Context

510(k) Submission Activity

92 total 510(k) submissions under product code LHN since 1985, with 92 receiving FDA clearance (average review time: 142 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - LHN Product Code

Recent submissions under LHN have taken an average of 196 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 →