510(k) · Cleared
Recalled · 2012High-Definition 120 Multileaf Collimator (HD120 MLC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on Aug 15, 2007 as substantially equivalent to K050442 (Varian Medical Systems, 2005) after a 26-day review. Its family tree reaches back 4 generations to 1995. 64 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 15, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926449 (1995). 6 ancestors in all. 64 later devices descend from it, 2 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 deviceK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007
- Descendant · cites it directly · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · cites it directly61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 2 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 3 generations on37descendants
- K123808AgilityElekta, Ltd. · 2013 · 3 generations on36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 4 generations on31descendants
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) | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | — |
| +1 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +2 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +3 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +3 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +4 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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: 90 lYE 3. Predicate Devices to claim substantial equivalence: Varian Medical Systems Millennium Multileaf Collimator - K050442 4. Description of the Device: The High-Definition 120 Multileaf Collimator (HD 120 MLC) provides higher resolu… | 2005 |
What descends from it? (64)
See all 642 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 |
|---|---|---|---|---|
| Jan 16, 2012 | Not classified | Z-1091-2012 | Device Design | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. |
| Jan 16, 2012 | Not classified | Z-1090-2012 | Device Design | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. |
| Jun 6, 2011 | Not classified | Z-3052-2011 | Device Design | When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. |
| Jan 30, 2008 | Not classified | Z-1459-2008 | Software design | Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K092871 (Varian Medical Systems, Inc., 2009) has gone furthest, with 61 descendants of its own.
- 2 other devices also cite its predicate K050442.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071992: High-Definition 120 Multileaf Collimator (HD120 MLC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071992
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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