510(k) · Cleared
Recalled · Class II · 2022S-250 Proton Beam Radiation Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mevion Medical Systems · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jun 4, 2012 as substantially equivalent to K060695 (Ion Beam Applications S.A., 2006) and 8 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1988. 5 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 4, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 12
- Predicates
- 9
Its longest line of descent runs back 5 generations to K872369 (1988). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 4 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 3 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 2 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 1 generation backK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
- This deviceK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012
- 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 · cites it directly · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
- Descendant · 3 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 · cites it directly2descendants
- K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025 · 2 generations on1descendant
- K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026 · 3 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 |
|---|---|---|---|---|---|
| −5 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −4 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −3 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −2 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −1 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
| 0 (this device) | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | — |
| +1 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| +1 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | 5 |
| +2 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025 | — |
| +3 | 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 |
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 | 1 | 0 |
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? (10)
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 |
|---|---|---|---|
| * | K060695 | Iba Proton Therapy System - Proteus 235Summary page 4…ces and Substantial Equivalence Determination 1) Harvard Cyclotron Lab * Harvard Cyclotron * Pre-Amendment 2) IBA " Proteus 235 Proton Therapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy… | 2006 |
| * | K053641 | Iba Proton Therapy System-Proteus 235Summary page 4…Substantial Equivalence Determination 1) Harvard Cyclotron Lab * Harvard Cyclotron * Pre-Amendment 2) IBA " Proteus 235 Proton Therapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy System… | 2006 |
| * | K061913 | Iba Proton Therapy System - Proteus 235Summary page 4…ial Equivalence Determination 1) Harvard Cyclotron Lab * Harvard Cyclotron * Pre-Amendment 2) IBA " Proteus 235 Proton Therapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy System * K872… | 2006 |
| * | K983332 | Northeast Proton Therapy CenterSummary page 4…termination 1) Harvard Cyclotron Lab * Harvard Cyclotron * Pre-Amendment 2) IBA " Proteus 235 Proton Therapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy System * K872369 4) Indiana Un… | 2001 |
| * | K983024 | Proton Therapy SystemSummary page 4…n 1) Harvard Cyclotron Lab * Harvard Cyclotron * Pre-Amendment 2) IBA " Proteus 235 Proton Therapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy System * K872369 4) Indiana University… | 2001 |
| * | K872369 | Loma Linda Univ. Proton Beam Therapy SystemSummary page 4…erapy System * [(060695, K053641,K061913,K[(53641, K983332,K[983024 3) LLUMC, Fermi National Accelerator Lab * Loma Linda University Proton Therapy System * K872369 4) Indiana University Cyclotron Facility * Proton Therapy System * [062891 5) Hitachi * PROBEAT * K053280 6) Var… | 1988 |
| * | K062891 | Proton Therapy SystemSummary page 4…rmi National Accelerator Lab * Loma Linda University Proton Therapy System * K872369 4) Indiana University Cyclotron Facility * Proton Therapy System * [062891 5) Hitachi * PROBEAT * K053280 6) Varian * pt2 varian proton therapy system * K101294 The S-250 and the device p… | 2006 |
| * | K053280 | ProbeatSummary page 4…ma Linda University Proton Therapy System * K872369 4) Indiana University Cyclotron Facility * Proton Therapy System * [062891 5) Hitachi * PROBEAT * K053280 6) Varian * pt2 varian proton therapy system * K101294 The S-250 and the device predicates produce a clinically viable… | 2006 |
| * | K101294 | PT2 Varian Proton Therapy SystemSummary page 4…ana University Cyclotron Facility * Proton Therapy System * [062891 5) Hitachi * PROBEAT * K053280 6) Varian * pt2 varian proton therapy system * K101294 The S-250 and the device predicates produce a clinically viable proton beam to be delivered to provide radiation therapy. The S-… | 2010 |
| * | — | Harvard Cyclotron Named without a submission number |
What descends from it? (5)
2 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 |
|---|---|---|---|---|
| Feb 1, 2022 | Class II | Z-0827-2022 | Component design/selection | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. |
| Jun 23, 2020 | Class II | Z-2686-2020 | Device Design | The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer. |
| May 15, 2020 | Class II | Z-2406-2020 | Software design | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off |
| Jun 29, 2018 | Class II | Z-2746-2018 | Device Design | QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged… |
| Dec 16, 2016 | Class II | Z-1122-2017 | Software design | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened |
| Oct 31, 2016 | Class II | Z-0409-2017 | Software design | Completing Setup Without Program Move Complete Can Cause An Isocenter Error |
| Oct 21, 2016 | Class II | Z-0410-2017 | Software Design Change | Recovery of Incorrect Isocenter -operational change |
| Oct 20, 2016 | Class II | Z-0411-2017 | Software design | Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter |
| Mar 15, 2016 | Class II | Z-1529-2016 | Device Design | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death. |
| Nov 18, 2015 | Class II | Z-0767-2016 | Labeling design | The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. |
| Nov 10, 2014 | Class II | Z-0588-2015 | Software design | Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more… |
| Mar 5, 2014 | Class II | Z-1271-2014 | Software design | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields |
The 5 latest of 12 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 24 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K152224 (Ion Beam Application S.A., 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K060695.
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. 2012, this device’s year, is highlighted.
FDA decisions per year · LHN
3in 2025
2007high 7 (2016) · low 0 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
2007high 194 (2026) · low 53 (2015)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
2007high 5 (2017) · low 0 (2009)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
2007high 24 (2021) · low 0 (2007)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 S-250 is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.
The S-250 is a medical device indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120676: S-250 Proton Beam Radiation 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/K120676
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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