510(k) · Cleared
ClearedProton Therapy Multileaf Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 24, 2009 as substantially equivalent to K050442 (Varian Medical Systems, 2005) after a 69-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Dec 24, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926449 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 3 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 2 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 1 generation backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- This deviceK093250 Proton Therapy Multileaf CollimatorVarian Medical Systems · 2009
- Descendant · cites it directly · 0 of its ownK152207 Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company · 2015
Most influential descendants
Showing 1 of 1 · See all- K152207Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −3 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −2 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −1 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| 0 (this device) | K093250 | Proton Therapy Multileaf Collimator | Varian Medical Systems | 2009 | — |
| +1 | K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K050442 | Millennium Multi-Leaf CollimatorSummary page 1…Product Code: LHN 3. Predicate Device to claim substantial equivalence: Varian Medical Systems Millennium Multileaf Collimator - K05 0442 4. Description of the Device: The Varian Proton Therapy Multileaf Collimator is an accessory proton beam collima… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152207 | Extended Range Shifter for PROBEAT-V | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K152207 (Hitachi, Ltd., Health Care Company, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K050442.
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. 2009, 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 Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093250: Proton Therapy Multileaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093250
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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