Product code LHN— Radiology
IBA PROTON THERAPY SYSTEM - PROTEUS 235
- Classification name
- System, Radiation Therapy, Charged-Particle, Medical
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Total cleared
- 92
- First cleared
- Most recent
Market context for product code LHN
FDA has cleared devices under product code LHN between 1985 and 2026, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code LHN
Recent clearances under product code LHN
- K260174 — PROBEAT-CR
- K252815 — ProBeam 360 Proton Therapy System v3.0
- K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- K243900 — eMotus Respiratory Motion Management System
- K242418 — P-Cure Proton Therapy System (PPTS)
- K232032 — PROBEAT-FR
- K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom)
- K221996 — P-Cure Proton Beam Therapy System
- K220883 — Small Field Applicator
- K221791 — ProBeam 360° Proton Therapy System
- K201798 — myQA iON
- K201042 — PROBEAT-CR
- K200282 — Orfit Aerial Couchtop
- K191821 — Blue Phantom PT
- K191521 — Radiance 330 Proton Beam Therapy System
- K191801 — PROBEAT-CR
- K181498 — X-ray Imaging System for the McLaren Proton Treatment System
- K181789 — VeriSuite
- K181676 — Mini Ridge Filter and auxiliary functions for PROBEAT-V
- K172848 — MEVION S250i Proton Beam Radiation Therapy Device
- K171049 — Real Time Image Gating System for Proton Beam Therapy Systems
- K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
- K170719 — Anzai Respiratory Gating System
- K162246 — ProNova SC360 Proton Therapy System
- K160612 — Sumitomo Proton Therapy System
- K152224 — Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
- K161163 — PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
- K160432 — Anzai Respiratory Gating System
- K153614 — PROBEAT-V and accessories
- K160063 — McLaren Proton Therapy System
- K152592 — PROBEAT-V
- K152207 — Extended Range Shifter for PROBEAT-V
- K151132 — PROBEAT-V
- K132919 — GANTRY BEAM LINE
- K133914 — VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
- K134052 — RADIANCE 330 PROTON THERAPY SYSTEM
- K133191 — PROBEAM PROTON THERAPY SYSTEM
- K132847 — I2C
- K130426 — SUMITOMO PROTON THERAPY SYSTEM
- K124002 — VERIFICATION CONSOLE
- K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEM
- K112969 — AIR-BAG SYSTEM
- K112981 — SUN 125C IONIZATION CHAMBER
- K112768 — CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
- K101294 — PT2 VARIAN PROTON THERAPY SYSTEM
- K102373 — CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
- K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K100766 — IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
- K093250 — PROTON THERAPY MULTILEAF COLLIMATOR
- K092796 — IBA PROTON THERAPY SYSTEM, PROTEUS 235
- K092653 — VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
- K091629 — PROTEUS 235 PROTON THERAPY SYSTEM
- K083058 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K082416 — IBA PROTON THERAPY SYSTEM- PROTEUS 235
- K080799 — ATLAS-BASED AUTOSEGMENTATION
- K080886 — IPLAN RT IMAGE
- K073059 — PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
- K071399 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
- K062891 — PROTON THERAPY SYSTEM
- K061913 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K061051 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
- K061152 — MUCHECK V7.0
- K060834 — PROBEAT WITH MGCS
- K060695 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K052118 — DOSE VERIFICATION SYSTEM
- K053280 — PROBEAT
- K053641 — IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K032511 — INTUITION IMAGE
- K032886 — DIAMOND SETUP 2000
- K031385 — ANZAI AZ-733 RESPIRATORY GATING SYSTEM
- K983332 — NORTHEAST PROTON THERAPY CENTER
- K983024 — PROTON THERAPY SYSTEM
- K002194 — TREATVISION
- K992414 — PROTON BEAM THERAPY SYSTEM (PBTS)
- K983660 — EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
- K983629 — RPM RESPIRATORY GATING SYSTEM
- K982952 — IMFAST
- K983342 — MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
- K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
- K981112 — MOBETRON
- K981358 — ARTOSCAN S
- K981115 — RADIO-PLAST
- K973960 — MODEL 37-185
- K972211 — MULTIDOS, QC6PLUS
- K972212 — 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
- K953391 — TREATMENT MANAGEMENT SYSTEM
- K891261 — INTRAOPERATIVE RADIATION THERAPY DEVICES
- K860606 — RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM
- K853964 — COMPUTERIZED RADIATION TREATMENT PLANNING SYS
- K851301 — TARGET CAT#B7850AA & B7850AB & B7850B
- K852907 — SIEMENS MEVATRON ME
Data sourced from openFDA. This site is unofficial and independent of the FDA.