510(k) · Cleared
ClearedRadiance 330 Proton Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protom International, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Mar 14, 2014 as substantially equivalent to K082416 (Ion Beam Applications S.A., 2008) and 2 other predicates after a 73-day review. Its family tree reaches back 5 generations to 1988. 4 later devices descend from it.
- Decided
- Mar 14, 2014
- Review
- 73 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K872369 (1988). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 4 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 3 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 2 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 1 generation backK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- This deviceK134052 Radiance 330 Proton Therapy SystemProtom International, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK191521 Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK221996 P-Cure Proton Beam Therapy SystemP-Cure, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK242418 P-Cure Proton Therapy System (PPTS)P-Cure, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK160063 McLaren Proton Therapy SystemMclaren Health Care Corporation · 2016
Most influential descendants
Showing 4 of 4 · See all- K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation · 2019 · cites it directly2descendants
- K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd. · 2023 · 2 generations on1descendant
- K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd. · 2025 · 3 generations on0descendants
- K160063McLaren Proton Therapy SystemMclaren Health Care Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −4 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −3 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −2 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −1 | K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | 2007 | 1 |
| 0 (this device) | K134052 | Radiance 330 Proton Therapy System | Protom International, Inc. | 2014 | — |
| +1 | K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | 2019 | — |
| +2 | K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023 | — |
| +3 | K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025 | — |
| +1 | K160063 | McLaren Proton Therapy System | Mclaren Health Care Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K082416 | Iba Proton Therapy System- Proteus 235Summary page 3…e and similar indications, principles of operation, and technological characteristics as the Ion Beam Applications Proton Therapy System with PPBS (K082416), Hitachi Ltd.'s PROBEAT with DSSS (K073059). and the Loma Linda Optivus Technology Proton Beam Therapy System (K99241… | 2008 |
| * | K073059 | Probeat with Discrete Spot Scanning SystemSummary page 3…of operation, and technological characteristics as the Ion Beam Applications Proton Therapy System with PPBS (K082416), Hitachi Ltd.'s PROBEAT with DSSS (K073059). and the Loma Linda Optivus Technology Proton Beam Therapy System (K992414). The minor differences between… | 2007 |
| * | K992414 | Proton Beam Therapy System (PBTS)Summary page 3…n Therapy System with PPBS (K082416), Hitachi Ltd.'s PROBEAT with DSSS (K073059). and the Loma Linda Optivus Technology Proton Beam Therapy System (K992414). The minor differences between the Radiance 3 3 0 Tm and the predicate devices do not raise any new questi… | 2000 |
What descends from it? (4)
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)
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 26 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K191521 (Protom International Holding Corporation, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K082416.
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?
The ProTom Radiance 330 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/K134052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134052: Radiance 330 Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134052
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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