510(k) · Cleared
ClearedVarian Multileaf Collimator with Dynamic Arc Therapy Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Nov 21, 1997 as substantially equivalent to K926449 (Varian Assoc., Inc., 1995) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1995. 70 later devices descend from it.
- Decided
- Nov 21, 1997
- Review
- 38 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K926449 (1995). 3 ancestors in all. 70 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- This deviceK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- Descendant · cites it directly · 69 of its ownK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- Descendant · 2 generations on · 67 of its ownK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- Descendant · 3 generations on · 64 of its ownK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- Descendant · 3 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K990085Millennium MLC -120Varian Assoc., Inc. · 1999 · cites it directly69descendants
- K050442Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · 2 generations on67descendants
- K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · 3 generations on64descendants
- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 3 generations on61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 4 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| 0 (this device) | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| +1 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| +2 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| +3 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| +3 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +4 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 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? (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 |
|---|---|---|---|
| * | K926449 | Varian Multileaf Collimator, Release 4.0Summary page 1…[email protected] Prepared: October 13, 1997 2. Device Name: Varian MultiLeaf Collimator with dynamic arc therapy feature 3. Predicate Varian MultiLeaf Collimator (K926449, K943224) Devices: BrainLAB micro-MultiLeaf Collimator (K970586) 4. Description: The Varian MultiLeaf Collimator (MLC) is an x-ra… | 1995 |
| * | K943224 | Varian Multileaf CollimatorSummary page 1…arian.com Prepared: October 13, 1997 2. Device Name: Varian MultiLeaf Collimator with dynamic arc therapy feature 3. Predicate Varian MultiLeaf Collimator (K926449, K943224) Devices: BrainLAB micro-MultiLeaf Collimator (K970586) 4. Description: The Varian MultiLeaf Collimator (MLC) is an x-ray collima… | 1996 |
| * | K970586 | Brainlab Micro Multi-Leaf CollimatorSummary page 1…Varian MultiLeaf Collimator with dynamic arc therapy feature 3. Predicate Varian MultiLeaf Collimator (K926449, K943224) Devices: BrainLAB micro-MultiLeaf Collimator (K970586) 4. Description: The Varian MultiLeaf Collimator (MLC) is an x-ray collimator designed to be mounted on a Varian Clinac® radiati… | 1997 |
What descends from it? (70)
See all 701 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990085 | Millennium MLC -120 | 1999 | 69 |
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?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K990085 (Varian Assoc., Inc., 1999) has gone furthest, with 69 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MultiLeaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In this the MLC performs the same function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac® finear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam’s eye view of the treatment volume at all times while the gantry is rotating in arc therapy.
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/K973889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973889: Varian Multileaf Collimator with Dynamic Arc Therapy Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973889
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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