510(k) · Cleared
Recalled · Class II · 2026Probeat-FR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jan 12, 2024 as substantially equivalent to K201042 (Hitachi, Ltd., 2020) after a 189-day review. Its family tree reaches back 9 generations to 1988. It has been recalled 4 times.
- Decided
- Jan 12, 2024
- Review
- 189 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 9 generations to K872369 (1988). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 5 generations between
- 3 generations backK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 2 generations backK191801 Probeat-CRHitachi, Ltd. · 2019 · Recalled
- 1 generation backK201042 Probeat-CRHitachi, Ltd. · 2020 · Recalled
- This deviceK232032 Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · 2024
Show all 9 generations
- Root · 9 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 8 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 7 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 6 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 5 generations backK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- 4 generations backK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 3 generations backK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 2 generations backK191801 Probeat-CRHitachi, Ltd. · 2019 · Recalled
- 1 generation backK201042 Probeat-CRHitachi, Ltd. · 2020 · Recalled
- This deviceK232032 Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −8 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −7 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −6 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −5 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| −4 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| −3 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| −2 | K191801 | Probeat-CR | Hitachi, Ltd. | 2019 | 1 |
| −1 | K201042 | Probeat-CR | Hitachi, Ltd. | 2020 | 1 |
| 0 (this device) | K232032 | Probeat-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024 | — |
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 |
|---|---|---|---|
| * | K201042 | Probeat-CRSummary page 5…: LHN, 21 C.F.R. § 892.5050 Predicate Device Hitachi Ltd., Healthcare Radiation Oncology Systems, Kashiwa, PROBEAT-CR Proton Beam Therapy Device (K201042) Device Description The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2026 | Class II | Z-1429-2026 | Software design | Software anomaly in the patient positioning system may result in positional discrepancy. |
| May 27, 2024 | Class II | Z-3125-2024 | Software design | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. |
| May 27, 2024 | Class II | Z-3126-2024 | Software design | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. |
| May 27, 2024 | Class II | Z-3127-2024 | Software design | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K201042.
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. 2024, 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-FR 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/K232032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232032: Probeat-FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232032
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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