510(k) · Cleared
Recalled · Class II · 2016Gantry Beam Line
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 10, 2014 as substantially equivalent to K101508 (Ion Beam Applications S.A., 2010) after a 296-day review. Its family tree reaches back 3 generations to 1988. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 10, 2014
- Review
- 296 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872369 (1988). 5 later devices descend from it, 1 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 backK101508 Modification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2010 · Recalled
- This deviceK132919 Gantry Beam LineIon Beam Applications S.A. · 2014
- Descendant · cites it directly · 4 of its ownK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK253406 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK163500 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus…Ion Beam Applications S.A. · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016 · cites it directly4descendants
- K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · 2 generations on2descendants
- K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025 · 3 generations on1descendant
- K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026 · 4 generations on0descendants
- K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A. · 2017 · 2 generations on0descendants
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 | K101508 | Modification to Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2010 | 6 |
| 0 (this device) | K132919 | Gantry Beam Line | Ion Beam Applications S.A. | 2014 | — |
| +1 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| +2 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | 5 |
| +3 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025 | — |
| +4 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026 | — |
| +2 | K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus… | Ion Beam Applications S.A. | 2017 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K101508 | Modification to Iba Proton Therapy System-Proteus 235 | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | 2016 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2016 | Class II | Z-2173-2018 | Employee error | IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. |
| May 18, 2016 | Class II | Z-2672-2017 | Employee error | Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K152224 (Ion Beam Application S.A., 2016) has gone furthest, with 4 descendants of its own.
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. 2014, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K132919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132919: Gantry Beam Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132919
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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