510(k) · Cleared

Recalled · 2012

Millennium Multi-Leaf Collimator

K050442510(k) SpecialCleared Mar 23, 200529-day reviewClass II21 CFR 892.5050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Medical Systems · IYE Accelerator, Linear, Medical

Cleared on Mar 23, 2005 as substantially equivalent to K990085 (Varian Assoc., Inc., 1999) after a 29-day review. Its family tree reaches back 3 generations to 1995. 67 later devices descend from it. It has been recalled 2 times.

Decided: Mar 23, 2005
Review: 29 days
Class: Class II
Product code: IYE
Recalls: 2
Predicates: 1

Its longest line of descent runs back 3 generations to K926449 (1995). 5 ancestors in all. 67 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
2 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
1 generation backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
This deviceK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005
Descendant · cites it directly · 64 of its ownK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
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

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2007high 9 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 67 · See all

K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · cites it directly64descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K926449	Varian Multileaf Collimator, Release 4.0	Varian Assoc., Inc.	1995	—
−2	K973889	Varian Multileaf Collimator with Dynamic Arc Therapy Feature	Varian Medical Systems, Inc.	1997	—
−1	K990085	Millennium MLC -120	Varian Assoc., Inc.	1999	2
0 (this device)	K050442	Millennium Multi-Leaf Collimator	Varian Medical Systems	2005	—
+1	K071992	High-Definition 120 Multileaf Collimator (HD120 MLC)	Varian Medical Systems	2007	4
+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

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
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

FIG. 1 — Lineage of K050442, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K990085	Millennium MLC -120 Summary page 1 …Product Code: 90 LYE 2. Predicate Devices to claim substantial equivalence: a. Varian Medical Systems' Millennium Multi-leaf Collimator (K990085) 3. Device Description: Millennium Multi-Leaf Collimator (MLC) Release v7.0 is a modification of…	Varian Assoc., Inc.	1999	2

Also cleared against K990085: 1 other device →

What descends from it? (67)

See all 67

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071992	High-Definition 120 Multileaf Collimator (HD120 MLC)	Varian Medical Systems	2007	64
K092871	Trilogy MX	Varian Medical Systems, Inc.	2009	61
K093250	Proton Therapy Multileaf Collimator	Varian Medical Systems	2009	1

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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K071992 (Varian Medical Systems, 2007) has gone furthest, with 64 descendants of its own.
1 other device also cites its predicate K990085.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)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 Millennium 120 Multi-leaf 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 static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050442 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050442: Millennium Multi-Leaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050442

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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