510(k) · Cleared
Recalled · Class II · 2014Probeam Proton Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jan 10, 2014 as substantially equivalent to K101294 (Varian Medical Systems, Oncology Systems, 2010) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963624 (1996). 8 ancestors in all, the oldest K872369 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 3 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 2 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- This deviceK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014
- Descendant · cites it directly · 2 of its ownK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252815 ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022 · cites it directly2descendants
- K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023 · 2 generations on1descendant
- K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −3 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −2 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −1 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| 0 (this device) | K133191 | Probeam Proton Therapy System | Varian Medical Systems | 2014 | — |
| +1 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| +2 | 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 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K101294 | PT2 Varian Proton Therapy SystemSummary page 1…Product Code: LHN Common/Usual Name: Proton Therapy System Predicate Devices: 1) ProBeam Proton Therapy System (K101294) 2) Varian On-board Imager Device (K042720) Device Description: ProBeam… | 2010 |
| * | K042720 | ON-Board Imager DeviceSummary page 1…rapy System Predicate Devices: 1) ProBeam Proton Therapy System (K101294) 2) Varian On-board Imager Device (K042720) Device Description: ProBeam Proton therapy system, has been designed by Varian Medical… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221791 | ProBeam 360° Proton Therapy System | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2014 | Class II | Z-1846-2014 | Under Investigation by firm | Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K221791 (Varian Medical Systems, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K101294.
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?
ProBeam 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/K133191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133191: Probeam Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133191
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