510(k) · Cleared
Recalled · Class II · 2015Probeat with Discrete Spot Scanning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi, Ltd., Power Systems Group · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 10, 2007 as substantially equivalent to K053280 (Hitachi, Ltd., Power Systems Group, 2006) and 2 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1988. 16 later devices descend from it. It has been recalled once.
- Decided
- Dec 10, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K872369 (1988). 7 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 3 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 2 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 1 generation backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- This deviceK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007
- Descendant · cites it directly · 10 of its ownK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · cites it directly · 7 of its ownK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK134052 Radiance 330 Proton Therapy SystemProtom International, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK191801 Probeat-CRHitachi, Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 2 of its ownK201042 Probeat-CRHitachi, Ltd. · 2020 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151132Probeat-VHitachi, Ltd., Health Care Company · 2015 · cites it directly10descendants
- K152592Probeat-VHitachi, Ltd., Health Care Company · 2015 · cites it directly7descendants
- K134052Radiance 330 Proton Therapy SystemProtom International, Inc. · 2014 · cites it directly4descendants
- K191801Probeat-CRHitachi, Ltd. · 2019 · 2 generations on3descendants
- K201042Probeat-CRHitachi, Ltd. · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −3 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −2 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −1 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| 0 (this device) | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | — |
| +1 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +1 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| +1 | K134052 | Radiance 330 Proton Therapy System | Protom International, Inc. | 2014 | — |
| +2 | K191801 | Probeat-CR | Hitachi, Ltd. | 2019 | 1 |
| +3 | K201042 | Probeat-CR | Hitachi, Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K053280 | ProbeatSummary page 2…same intended use and indications, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT (K053280), PROBEAT with MGCS (060834), and IBA Proton Therapy System - Proteus 235 (K060695). The only difference between the PROBEAT with… | 2006 |
| * | K060834 | Probeat with MGCSSummary page 2…tions, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT (K053280), PROBEAT with MGCS (060834), and IBA Proton Therapy System - Proteus 235 (K060695). The only difference between the PROBEAT with DSSS and the cleared PROBEA… | 2006 |
| * | K060695 | Iba Proton Therapy System - Proteus 235Summary page 2…operation and technological characteristics, as compared to Hitachi's cleared PROBEAT (K053280), PROBEAT with MGCS (060834), and IBA Proton Therapy System - Proteus 235 (K060695). The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System… | 2006 |
What descends from it? (16)
See all 163 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 |
|---|---|---|---|---|
| Apr 21, 2015 | Class II | Z-1838-2015 | Device Design | At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K151132 (Hitachi, Ltd., Health Care Company, 2015) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K053280.
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. 2007, 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?
Hitachi's PROBEAT with DSSS is a medical device 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/K073059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073059: Probeat with Discrete Spot Scanning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073059
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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