510(k) · Cleared
ClearedIba Proton Therapy System-Proteus 235
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ion Beam Applications S.A. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jan 24, 2006 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1988. 25 later devices descend from it.
- Decided
- Jan 24, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872369 (1988). 25 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 1 generation backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- This deviceK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- Descendant · cites it directly · 24 of its ownK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- Descendant · 3 generations on · 10 of its ownK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · 2 generations on · 6 of its ownK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K060695Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · cites it directly24descendants
- K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · 2 generations on16descendants
- K151132Probeat-VHitachi, Ltd., Health Care Company · 2015 · 3 generations on10descendants
- K152592Probeat-VHitachi, Ltd., Health Care Company · 2015 · 3 generations on7descendants
- K062891Proton Therapy SystemIndiana University Cyclotron Facility · 2006 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −1 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| 0 (this device) | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| +1 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| +2 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| +3 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +3 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +2 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K872369 | Loma Linda Univ. Proton Beam Therapy SystemSummary page 1…Device Modification described below is substantially equivalent to the previously cleared Loma Linda University Medical Center ("Loma Linda") Proton Beam Therapy device (K872369), the Harvard University Cyclotron Laboratory Proton Beam Therapy device, a pre-1976 device and the Ion Beam Appliacionts (IBA) P… | 1988 |
| * | K983024 | Proton Therapy SystemSummary page 1…py device (K872369), the Harvard University Cyclotron Laboratory Proton Beam Therapy device, a pre-1976 device and the Ion Beam Appliacionts (IBA) Proton Therapy System (K983024) The PTS with the Device Modification and its predicate devices have the same intended use and principles of operation, and are s… | 2001 |
| * | — | Harvard University Cyclotron Laboratory Proton Beam Therapy device Named without a submission number |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060695 (Ion Beam Applications S.A., 2006) has gone furthest, with 24 descendants of its own.
- 8 other devices also cite its predicate K872369.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053641: Iba Proton Therapy System-Proteus 235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053641
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026