510(k) · Cleared
Recalled · Class II · 2026IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
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 Aug 17, 2017 as substantially equivalent to K152224 (Ion Beam Application S.A., 2016) after a 247-day review. Its family tree reaches back 7 generations to 1988. It has been recalled 11 times.
- Decided
- Aug 17, 2017
- Review
- 247 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 7 generations to K872369 (1988). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 6 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 5 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 4 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 3 generations backK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
- 2 generations backK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
- 1 generation backK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
- This deviceK163500 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus…Ion Beam Applications S.A. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −6 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −5 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −4 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −3 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
| −2 | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | 12 |
| −1 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| 0 (this device) | K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus… | Ion Beam Applications S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Summary page 5…– Proteus 235 (PTS) with the addition of the IBA wireless hand- pendant System is substantially equivalent to the previously cleared IBA Proton Therapy System (K152224). The current PTS and its Primary predicate device have the same intended use and principles of operation, and are substanti… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2026 | Class II | Z-1497-2026 | Software design | It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external… |
| Jul 10, 2024 | Class II | Z-2693-2024 | Process design | Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues |
| Jul 8, 2024 | Class II | Z-3089-2024 | Under Investigation by firm | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime |
| May 10, 2024 | Class II | Z-1945-2024 | Device Design | Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances |
| Mar 4, 2024 | Class II | Z-1603-2024 | Device Design | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. |
| Sep 18, 2023 | Class II | Z-0295-2024 | Device Design | The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. |
| Apr 20, 2022 | Class II | Z-1205-2022 | Under Investigation by firm | First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed |
| Feb 15, 2022 | Class II | Z-0747-2022 | Device Design | When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range… |
| Nov 29, 2021 | Class II | Z-0466-2022 | Device Design | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment… |
| Jul 17, 2020 | Class II | Z-2715-2020 | Software design | IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. |
| Apr 21, 2020 | Class II | Z-2773-2020 | Software design | Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K152224.
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. 2017, this device’s year, is highlighted.
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 IBA Proton Therapy System (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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
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/K163500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163500: IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163500
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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