FDA Product Code
FDA Product Code LHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 93 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260597 | VIRTUE QA | ProNova Solutions | 2026-09-23 | Traditional | PDF ↗ |
| K260174 | PROBEAT-CR | Hitachi High-Tech Corp. | 2026-06-11 | Traditional | PDF ↗ |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026-04-23 | Traditional | PDF ↗ |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026-03-25 | Traditional | PDF ↗ |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025-09-12 | Traditional | PDF ↗ |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | 2025-06-27 | Traditional | PDF ↗ |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025-05-12 | Traditional | PDF ↗ |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 | Traditional | PDF ↗ |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023-03-20 | Traditional | PDF ↗ |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 | Traditional | PDF ↗ |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022-12-01 | Traditional | PDF ↗ |
| K201798 | myQA iON | Iba Dosimetry GmbH | 2020-07-17 | Traditional | PDF ↗ |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | 2020-07-13 | Traditional | PDF ↗ |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | 2020-04-08 | Traditional | PDF ↗ |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | 2020-01-23 | Abbreviated | PDF ↗ |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | 2019-09-27 | Traditional | PDF ↗ |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | 2019-09-13 | Traditional | PDF ↗ |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | 2018-12-10 | Traditional | PDF ↗ |
| K181789 | VeriSuite | Medcom GmbH | 2018-09-21 | Abbreviated | PDF ↗ |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 | Traditional | PDF ↗ |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017-12-27 | Traditional | PDF ↗ |
| K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | 2017-12-26 | Traditional | PDF ↗ |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. | 2017-08-17 | Traditional | PDF ↗ |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2017-04-05 | Special | PDF ↗ |
| K162246 | ProNova SC360 Proton Therapy System | Pronova Solutions, LLC | 2016-12-08 | Traditional | PDF ↗ |
| K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | 2016-08-17 | Traditional | PDF ↗ |
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016-08-09 | Traditional | PDF ↗ |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Hitachi , Ltd. | 2016-07-13 | Traditional | PDF ↗ |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2016-04-22 | Traditional | PDF ↗ |
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | 2016-04-21 | Traditional | PDF ↗ |
| K160063 | McLaren Proton Therapy System | Mclaren Health Care Corporation | 2016-02-25 | Traditional | PDF ↗ |
| K152592 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-11-02 | Traditional | PDF ↗ |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-10-02 | Traditional | PDF ↗ |
| K151132 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-06-01 | Traditional | PDF ↗ |
| K132919 | GANTRY BEAM LINE | Ion Beam Applications S.A. | 2014-07-10 | Traditional | PDF ↗ |
| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | Medcom GmbH | 2014-04-03 | Abbreviated | PDF ↗ |
| K134052 | RADIANCE 330 PROTON THERAPY SYSTEM | Protom International, Inc. | 2014-03-14 | Traditional | PDF ↗ |
| K133191 | PROBEAM PROTON THERAPY SYSTEM | Varian Medical Systems | 2014-01-10 | Traditional | PDF ↗ |
| K132847 | I2C | Ion Beam Applications S.A. | 2013-11-20 | Traditional | PDF ↗ |
| K130426 | SUMITOMO PROTON THERAPY SYSTEM | Sumitomo Heavy Industries, Ltd. | 2013-11-19 | Traditional | PDF ↗ |
| K124002 | VERIFICATION CONSOLE | Varian Medical Systems | 2013-02-21 | Traditional | PDF ↗ |
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | Mevion Medical Systems | 2012-06-04 | Traditional | PDF ↗ |
| K112969 | AIR-BAG SYSTEM | Niigata Mechatronics Co., Ltd. | 2012-03-14 | Traditional | PDF ↗ |
| K112981 | SUN 125C IONIZATION CHAMBER | Sun Nuclear Corp. | 2012-01-25 | Traditional | PDF ↗ |
| K112768 | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2011-11-18 | Traditional | PDF ↗ |
| K101294 | PT2 VARIAN PROTON THERAPY SYSTEM | Varian Medical Systems, Oncology Systems | 2010-12-27 | Traditional | PDF ↗ |
| K102373 | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2010-09-30 | Special | PDF ↗ |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | Ion Beam Applications S.A. | 2010-08-06 | Special | PDF ↗ |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | Ion Beam Applications S.A. | 2010-07-21 | Traditional | PDF ↗ |
| K093250 | PROTON THERAPY MULTILEAF COLLIMATOR | Varian Medical Systems | 2009-12-24 | Traditional | PDF ↗ |
| K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | Ion Beam Applications S.A. | 2009-12-22 | Traditional | PDF ↗ |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | Medcom GmbH | 2009-09-18 | Special | PDF ↗ |
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM | Ion Beam Applications S.A. | 2009-08-11 | Traditional | PDF ↗ |
| K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | 2009-04-15 | Traditional | PDF ↗ |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | Ion Beam Applications S.A. | 2008-12-12 | Traditional | PDF ↗ |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Computerized Medical Systems, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K080886 | IPLAN RT IMAGE | Brainlab AG | 2008-06-24 | Traditional | PDF ↗ |
| K073059 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM | Hitachi, Ltd., Power Systems Group | 2007-12-10 | Special | PDF ↗ |
| K071399 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 | Sicel Technologies, Inc. | 2007-06-20 | Special | PDF ↗ |
| K062891 | PROTON THERAPY SYSTEM | Indiana University Cyclotron Facility | 2006-12-14 | Traditional | PDF ↗ |
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | 2006-07-28 | Special | PDF ↗ |
| K061051 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER | Sicel Technologies, Inc. | 2006-06-13 | Traditional | PDF ↗ |
| K061152 | MUCHECK V7.0 | Oncology Data Systems, Inc. | 2006-05-10 | Traditional | PDF ↗ |
| K060834 | PROBEAT WITH MGCS | Hitachi , Ltd. | 2006-04-19 | Special | PDF ↗ |
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | 2006-04-11 | Special | PDF ↗ |
| K052118 | DOSE VERIFICATION SYSTEM | Sicel Technologies, Inc. | 2006-04-03 | Traditional | PDF ↗ |
| K053280 | PROBEAT | Hitachi, Ltd., Power Systems Group | 2006-03-09 | Traditional | PDF ↗ |
| K053641 | IBA PROTON THERAPY SYSTEM-PROTEUS 235 | Ion Beam Applications S.A. | 2006-01-24 | Special | PDF ↗ |
| K032511 | INTUITION IMAGE | Brainlab AG | 2004-01-21 | Traditional | PDF ↗ |
| K032886 | DIAMOND SETUP 2000 | K&S Assoc., Inc. | 2004-01-09 | Traditional | PDF ↗ |
| K031385 | ANZAI AZ-733 RESPIRATORY GATING SYSTEM | Anzai Medical Co., Ltd. | 2003-11-10 | Traditional | PDF ↗ |
| K983332 | NORTHEAST PROTON THERAPY CENTER | Massachusetts General Hospital | 2001-07-20 | Traditional | PDF ↗ |
| K983024 | PROTON THERAPY SYSTEM | Ion Beam Applications S.A. | 2001-07-12 | Traditional | PDF ↗ |
| K002194 | TREATVISION | Varian Medical Systems, Inc. | 2000-08-18 | Special | PDF ↗ |
| K992414 | PROTON BEAM THERAPY SYSTEM (PBTS) | Optivus Technology, Inc. | 2000-07-21 | Traditional | PDF ↗ |
| K983660 | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) | Brainlab, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K983629 | RPM RESPIRATORY GATING SYSTEM | Varian Medical Systems, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K982952 | IMFAST | Siemens Medical Solutions USA, Inc. | 1999-03-05 | Traditional | PDF ↗ |
| K983342 | MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE | Philips Medical Systems (Cleveland), Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | Victoreen, Inc. | 1998-11-19 | Traditional | PDF ↗ |
| K981112 | MOBETRON | Intraop Medical, Inc. | 1998-07-24 | Traditional | PDF ↗ |
| K981358 | ARTOSCAN S | Biosound Esaote, Inc. | 1998-07-13 | Traditional | PDF ↗ |
| K981115 | RADIO-PLAST | Smith & Nephew, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K973960 | MODEL 37-185 | Victoreen, Inc. | 1998-01-14 | Traditional | PDF ↗ |
| K972211 | MULTIDOS, QC6PLUS | Ptw-New York Corp. | 1997-09-10 | Traditional | PDF ↗ |
| K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER | Ptw-New York Corp. | 1997-09-10 | Traditional | PDF ↗ |
| K953391 | TREATMENT MANAGEMENT SYSTEM | Siemens Medical Solutions USA, Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K891261 | INTRAOPERATIVE RADIATION THERAPY DEVICES | General Electric Co. | 1989-04-26 | Traditional | PDF ↗ |
| K860606 | RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM | Bionix Corp. | 1986-03-20 | Traditional | PDF ↗ |
| K853964 | COMPUTERIZED RADIATION TREATMENT PLANNING SYS | Computerized Medical Systems, Inc. | 1985-12-05 | Traditional | PDF ↗ |
| K851301 | TARGET CAT#B7850AA & B7850AB & B7850B | General Electric Co. | 1985-09-20 | Traditional | PDF ↗ |
| K852907 | SIEMENS MEVATRON ME | Siemens Medical Laboratories, Inc. | 1985-09-19 | Traditional | PDF ↗ |
Product code LHN · Class II · Radiology. Data: openFDA.