510(k) · Cleared
ClearedProton Therapy System
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 Jul 12, 2001 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) after a 1,046-day review. Its family tree reaches back 1 generation to 1988. 34 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 1,046 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872369 (1988). 34 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- This deviceK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- Descendant · cites it directly · 26 of its ownK053280 ProbeatHitachi, Ltd., Power Systems Group · 2006
- Descendant · cites it directly · 25 of its ownK053641 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 · 17 of its ownK060834 Probeat with MGCSHitachi, Ltd. · 2006
- Descendant · 2 generations on · 16 of its ownK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K053280ProbeatHitachi, Ltd., Power Systems Group · 2006 · cites it directly26descendants
- K053641Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006 · cites it directly25descendants
- K060695Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · cites it directly24descendants
- K060834Probeat with MGCSHitachi, Ltd. · 2006 · 2 generations on17descendants
- K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| 0 (this device) | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| +1 | K053280 | Probeat | Hitachi, Ltd., Power Systems Group | 2006 | — |
| +1 | 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 | K060834 | Probeat with MGCS | Hitachi, Ltd. | 2006 | — |
| +2 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 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? (2)
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….5050). Predicate Devices The PTS is substantially equivalent to the previously cleared Loma Linda University Medical Center ("Loma Linda") Proton Beam Therapy device (K872369) and the Harvard University Cyclotron Laboratory Proton Beam Therapy device, a pre-1976 device. The PTS and its predicate devices… | 1988 |
| * | — | Harvard University Cyclotron Laboratory Proton Beam Therapy device Named without a submission number |
What descends from it? (34)
See all 348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053280 | Probeat | 2006 | 26 |
| K053641 | Iba Proton Therapy System-Proteus 235 | 2006 | 25 |
| K060695 | Iba Proton Therapy System - Proteus 235 | 2006 | 24 |
| K101508 | Modification to Iba Proton Therapy System-Proteus 235 | 2010 | 6 |
| K062891 | Proton Therapy System | 2006 | 6 |
| K120676 | S-250 Proton Beam Radiation Therapy System | 2012 | 5 |
| K100766 | Iba Proton Therapy System, Model Proteus 235 | 2010 | 0 |
| K092796 | Iba Proton Therapy System, Proteus 235 | 2009 | 0 |
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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983024: Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983024
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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