510(k) · Cleared
ClearedPROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi, Ltd. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jul 13, 2016 as substantially equivalent to K152592 (Hitachi, Ltd., Health Care Company, 2015) after a 79-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jul 13, 2016
- Review
- 79 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K872369 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 6 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 5 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 4 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 3 generations backK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- 2 generations backK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 1 generation backK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- This deviceK161163 PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −6 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −5 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −4 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −3 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| −2 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| −1 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| 0 (this device) | K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Hitachi, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K152592 | Probeat-VSummary page 5…ystem Classification Name Medical Charged-Particle Radiation Therapy System, 21 C.F.R. § 892.5050, Product Code LHN Predicate Devices PROBEAT-V (K152592) Intended Use / Indications for Use The PROBEAT-V with X-ray Limiting Accessory is a medical device designed to produce… | 2015 |
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 28 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K152592.
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. 2016, 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 PROBEAT-V with X-ray Limiting Accessory is a medical devices designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161163: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161163
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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