Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LHN — Predicate Candidate Screening
92 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
263 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260174 | PROBEAT-CR | Hitachi High-Tech Corp. | 2026-06-11 | 141 | 0 |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026-04-23 | 231 | 0 |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026-03-25 | 176 | 0 |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025-09-12 | 165 | 0 |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | 2025-06-27 | 190 | 0 |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025-05-12 | 270 | 0 |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 | 189 | 4 |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023-10-06 | 105 | 0 |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023-03-20 | 257 | 0 |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 | 265 | 0 |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022-12-01 | 163 | 0 |
| K201798 | myQA iON | Iba Dosimetry GmbH | 2020-07-17 | 17 | 1 |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | 2020-07-13 | 84 | 1 |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | 2020-04-08 | 64 | 0 |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | 2020-01-23 | 199 | 0 |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | 2019-09-27 | 112 | 0 |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | 2019-09-13 | 72 | 1 |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | 2018-12-10 | 186 | 0 |
| K181789 | VeriSuite | Medcom GmbH | 2018-09-21 | 78 | 0 |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 | 51 | 0 |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017-12-27 | 99 | 0 |
| K171049 | Real Time Image Gating System for Proton Beam Therapy System | Hitachi, Ltd. Healthcare | 2017-12-26 | 263 | 0 |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus | Ion Beam Applications S.A. | 2017-08-17 | 247 | 7 |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2017-04-05 | 27 | 0 |
| K162246 | ProNova SC360 Proton Therapy System | Pronova Solutions, LLC | 2016-12-08 | 120 | 0 |
| K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | 2016-08-17 | 167 | 0 |
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Pl | Ion Beam Application S.A. | 2016-08-09 | 368 | 2 |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Acc | Hitachi , Ltd. | 2016-07-13 | 79 | 0 |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2016-04-22 | 66 | 0 |
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | 2016-04-21 | 126 | 0 |
| K160063 | McLaren Proton Therapy System | Mclaren Health Care Corporation | 2016-02-25 | 43 | 0 |
| K152592 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-11-02 | 53 | 0 |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-10-02 | 57 | 0 |
| K151132 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-06-01 | 34 | 0 |
| K132919 | GANTRY BEAM LINE | Ion Beam Applications S.A. | 2014-07-10 | 296 | 0 |
| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE- | Medcom GmbH | 2014-04-03 | 101 | 0 |
| K134052 | RADIANCE 330 PROTON THERAPY SYSTEM | Protom International, Inc. | 2014-03-14 | 73 | 0 |
| K133191 | PROBEAM PROTON THERAPY SYSTEM | Varian Medical Systems | 2014-01-10 | 85 | 1 |
| K132847 | I2C | Ion Beam Applications S.A. | 2013-11-20 | 70 | 1 |
| K130426 | SUMITOMO PROTON THERAPY SYSTEM | Sumitomo Heavy Industries, Ltd. | 2013-11-19 | 272 | 0 |
| K124002 | VERIFICATION CONSOLE | Varian Medical Systems | 2013-02-21 | 57 | 0 |
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | Mevion Medical Systems | 2012-06-04 | 91 | 8 |
| K112969 | AIR-BAG SYSTEM | Niigata Mechatronics Co., Ltd. | 2012-03-14 | 161 | 0 |
| K112981 | SUN 125C IONIZATION CHAMBER | Sun Nuclear Corp. | 2012-01-25 | 111 | 0 |
| K112768 | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2011-11-18 | 57 | 0 |
| K101294 | PT2 VARIAN PROTON THERAPY SYSTEM | Varian Medical Systems, Oncology Systems | 2010-12-27 | 231 | 0 |
| K102373 | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | 2010-09-30 | 41 | 0 |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | Ion Beam Applications S.A. | 2010-08-06 | 66 | 2 |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | Ion Beam Applications S.A. | 2010-07-21 | 126 | 0 |
| K093250 | PROTON THERAPY MULTILEAF COLLIMATOR | Varian Medical Systems | 2009-12-24 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda