510(k) · Cleared
ClearedProton Beam Therapy System (PBTS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optivus Technology, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jul 21, 2000 as substantially equivalent to K872369 (Loma Linda University Medical Center, 1988) after a 367-day review. Its family tree reaches back 1 generation to 1988. 27 later devices descend from it.
- Decided
- Jul 21, 2000
- Review
- 367 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872369 (1988). 27 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- This deviceK992414 Proton Beam Therapy System (PBTS)Optivus Technology, Inc. · 2000
- Descendant · cites it directly · 26 of its ownK053280 ProbeatHitachi, Ltd., Power Systems Group · 2006
- Descendant · 2 generations on · 17 of its ownK060834 Probeat with MGCSHitachi, Ltd. · 2006
- Descendant · 2 generations on · 16 of its ownK073059 Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · Recalled
- Descendant · 3 generations on · 10 of its ownK151132 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK152592 Probeat-VHitachi, Ltd., Health Care Company · 2015 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K053280ProbeatHitachi, Ltd., Power Systems Group · 2006 · cites it directly26descendants
- K060834Probeat with MGCSHitachi, Ltd. · 2006 · 2 generations on17descendants
- K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group · 2007 · 2 generations on16descendants
- K151132Probeat-VHitachi, Ltd., Health Care Company · 2015 · 3 generations on10descendants
- K152592Probeat-VHitachi, Ltd., Health Care Company · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| 0 (this device) | K992414 | Proton Beam Therapy System (PBTS) | Optivus Technology, Inc. | 2000 | — |
| +1 | K053280 | Probeat | Hitachi, Ltd., Power Systems Group | 2006 | — |
| +2 | K060834 | Probeat with MGCS | Hitachi, Ltd. | 2006 | — |
| +2 | 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 |
| +3 | K152592 | Probeat-V | Hitachi, Ltd., Health Care Company | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K872369 | Loma Linda Univ. Proton Beam Therapy SystemSummary page 1…ntially equivalent to the Loma Linda University Medical Center (LLUMC) PBTS. The LLUMC PBTS was cleared for marketing in the United States in the premarket notification, K872369. Optivus Technology, Inc. 510(k) 7/19/99 Proton Beam Therapy System Page F-1 43 K99z41¢ The Optivus Proton Beam… | 1988 |
What descends from it? (27)
See all 272 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?
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.
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 Optivus Technology, Inc.’s Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects the patient from unnecessary exposure to radiation and other hazards.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992414 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992414: Proton Beam Therapy System (PBTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992414
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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