510(k) · Cleared
ClearedProBeam 360 Proton Therapy System v3.0
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 Apr 23, 2026 as substantially equivalent to K221791 (Varian Medical Systems, Inc., 2022) and 1 other predicate after a 231-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 23, 2026
- Review
- 231 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963624 (1996). 14 ancestors in all, the oldest K872369 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 6 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 5 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- 3 generations backK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014 · Recalled
- 2 generations backK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- 1 generation backK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- This deviceK252815 ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −6 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −5 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −4 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| −3 | K133191 | Probeam Proton Therapy System | Varian Medical Systems | 2014 | 1 |
| −2 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| −1 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K221791 | ProBeam 360° Proton Therapy SystemSummary page 5…apy, Charged-Particle, Medical Regulation Number: §892.5050 Product Code: LHN III. Predicate Devices ProBeam 360° Proton Therapy System v1.0 (K221791) (single room configuration) ProBeam 360° Proton Therapy System v2.0 (K231863) (multiroom configuration) IV. Device… | 2022 |
| * | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom)Summary page 5…de: LHN III. Predicate Devices ProBeam 360° Proton Therapy System v1.0 (K221791) (single room configuration) ProBeam 360° Proton Therapy System v2.0 (K231863) (multiroom configuration) IV. Device Description The ProBeam 360° Proton Therapy System version 3.0 (ProBeam 360° System v3… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 9 of the 14 ancestors have a recall of any class.
- 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. 2026, 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 as stated in the FDA summary.
https://510kreport.com/device/K252815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252815: ProBeam 360 Proton Therapy System v3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252815
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026