510(k) · Cleared
Recalled · Class II · 2018Iba 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 Apr 11, 2006 as substantially equivalent to K983024 (Ion Beam Applications S.A., 2001) and 1 other predicate after a 26-day review. Its family tree reaches back 3 generations to 1988. 24 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 11, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872369 (1988). 24 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 2 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 1 generation backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- This deviceK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006
- Descendant · cites it directly · 16 of its ownK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- Descendant · 2 generations on · 10 of its ownK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · cites it directly · 6 of its ownK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
- Descendant · cites it directly · 5 of its ownK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · cites it directly16descendants
- K151132Probeat-VHitachi, Ltd., Health Care Company · 2015 · 2 generations on10descendants
- K152592Probeat-VHitachi, Ltd., Health Care Company · 2015 · 2 generations on7descendants
- K062891Proton Therapy SystemIndiana University Cyclotron Facility · 2006 · cites it directly6descendants
- K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −2 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −1 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| 0 (this device) | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| +1 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| +2 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +2 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +1 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
| +1 | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | 12 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K983024 | Proton Therapy SystemSummary page 1…972-1906 E-Mail: ireisscsaul.com Classification Name Medical charged-particle radiation therapy systems (21 C.F.R. §892.5050) Predicate Device PROTON THERAPY SYSTEM (K983024) and IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641) MID 9575 Rev A… | 2001 |
| * | K053641 | Iba Proton Therapy System-Proteus 235Summary page 1…radiation therapy systems (21 C.F.R. §892.5050) Predicate Device PROTON THERAPY SYSTEM (K983024) and IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641) MID 9575 Rev A Page 1/2 Description of the de… | 2006 |
What descends from it? (24)
See all 243 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2018 | Class II | Z-2470-2018 | Device Design | Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the… |
| Dec 5, 2017 | Class II | Z-0934-2018 | Device Design | An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate. |
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 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073059 (Hitachi, Ltd., Power Systems Group, 2007) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K983024.
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/K060695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060695: 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/K060695
Report an extraction error
Are you the manufacturer?
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