510(k) · Cleared
Recalled · Class II · 2026Probeat-CR
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, 2020 as substantially equivalent to K191801 (Hitachi, Ltd., 2019) after an 84-day review. Its family tree reaches back 8 generations to 1988. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K872369 (1988). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 7 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 6 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 5 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 4 generations backK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- 3 generations backK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 2 generations backK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- 1 generation backK191801 Probeat-CRHitachi, Ltd. · 2019 · Recalled
- This deviceK201042 Probeat-CRHitachi, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK260174 Probeat-CRHitachi High-Tech Corp. · 2026
- Descendant · cites it directly · 0 of its ownK232032 Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · 2024 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −7 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −6 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −5 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −4 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| −3 | K151132 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| −2 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
| −1 | K191801 | Probeat-CR | Hitachi, Ltd. | 2019 | 1 |
| 0 (this device) | K201042 | Probeat-CR | Hitachi, Ltd. | 2020 | — |
| +1 | K260174 | Probeat-CR | Hitachi High-Tech Corp. | 2026 | — |
| +1 | K232032 | Probeat-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024 | 4 |
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 |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K191801 | Probeat-CRSummary page 4…egulatory Class: Class II Product Code: LHN Predicate Devices Hitachi Ltd., Healthcare Hitachi Works, PROBEAT-CR Proton Beam Therapy Device (K191801) Reference Devices Hitachi Ltd., Healthcare Hitachi Works, Real Time Image Gating System for Proton Beam Therapy Sy… | 2019 |
| † | K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | 2017 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Feb 6, 2026 | Class II | Z-1430-2026 | Software design | Software anomaly in the patient positioning system may result in positional discrepancy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K260174 (Hitachi High-Tech Corp., 2026) has gone furthest, with 0 descendants of its own.
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. 2020, 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-CR 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/K201042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201042: Probeat-CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201042
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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