510(k) · Cleared
ClearedProBeam 360° Proton Therapy System v2.0 (Multiroom)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Oct 6, 2023 as substantially equivalent to K221791 (Varian Medical Systems, Inc., 2022) after a 105-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Oct 6, 2023
- Review
- 105 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963624 (1996). 13 ancestors in all, the oldest K872369 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 5 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 4 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- 2 generations backK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014 · Recalled
- 1 generation backK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- This deviceK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252815 ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −5 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −4 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −3 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| −2 | K133191 | Probeam Proton Therapy System | Varian Medical Systems | 2014 | 1 |
| −1 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| 0 (this device) | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| +1 | K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K221791 | ProBeam 360° Proton Therapy SystemSummary page 4…rapy, Charged-Particle, Medical Regulation Number: §892.5050 Product Code: LHN III. Predicate Device ProBeam 360° Proton Therapy System v1.0 (K221791) IV. Reference Device ProBeam Proton Therapy System v2.0 (K133191) V. Device Description The ProBeam 3… | 2022 |
| † | K133191 | Probeam Proton Therapy System | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252815 | ProBeam 360 Proton Therapy System v3.0 | 2026 | 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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 9 of the 13 ancestors have a recall of any class.
- Of its descendants, K252815 (Varian Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221791.
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. 2023, 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?
ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
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/K231863 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231863: ProBeam 360° Proton Therapy System v2.0 (Multiroom).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231863
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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