510(k) · Cleared

Cleared

Beam Modulator, Model 4513 332 8000

K042794510(k) TraditionalCleared Jan 31, 2005116-day reviewClass II21 CFR 892.5050

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

Elekta, Ltd. · IYE Accelerator, Linear, Medical

Cleared on Jan 31, 2005 as substantially equivalent to K904124 (Philips Medical Systems, Inc., 1991) and 3 other predicates after a 116-day review. Its family tree reaches back 3 generations to 1995.

Decided: Jan 31, 2005
Review: 116 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K926449 (1995). 10 ancestors in all, the oldest K904124 (1991). No later device cites it as a predicate yet.

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 deviceK042794 Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005

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)	K042794	Beam Modulator, Model 4513 332 8000	Elekta, Ltd.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1996	2	0
1997	1	0
2000	1	0
2001	1	0
2003	1	0

FIG. 1 — Lineage of K042794, 1995–2005Source: 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? (4)

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
*	K904124	Philips Multileaf Collimator (MLC) Summary page 1 …ModulatorTM. This information is summarised as follows: - 1. The Beam ModulatorTM is an enhancement to the previously reported MLC multileaf collimator, D.C. Number K904124, and the MLCi, multileaf collimator, D.C. Number K963624. Other predicate devices are the Millennium multileaf collimator f…	Philips Medical Systems, Inc.	1991	—
*	K963624	Philips Sli Series Linear Accelerator Summary page 1 …1. The Beam ModulatorTM is an enhancement to the previously reported MLC multileaf collimator, D.C. Number K904124, and the MLCi, multileaf collimator, D.C. Number K963624. Other predicate devices are the Millennium multileaf collimator from Varian Assoc. Inc., D.C. number K990085 and the Moduleaf…	Philips Medical Systems, Inc.	1996	2
*	K990085	Millennium MLC -120 Summary page 1 …4124, and the MLCi, multileaf collimator, D.C. Number K963624. Other predicate devices are the Millennium multileaf collimator from Varian Assoc. Inc., D.C. number K990085 and the Moduleaf multileaf collimator from MRC Systems GmbH, D.C. number K030609. These devices have an established and pr…	Varian Assoc., Inc.	1999	2
*	K030609	Moduleaf Summary page 1 …vices are the Millennium multileaf collimator from Varian Assoc. Inc., D.C. number K990085 and the Moduleaf multileaf collimator from MRC Systems GmbH, D.C. number K030609. These devices have an established and proven track record for safety. The primary reason for the introduction of this pro…	Mrc Systems GmbH	2003	1

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
5 of the 10 ancestors have a recall of any class.

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 Elekta Beam Modulator is an X-ray collimator, designed to be used with the Elckta range of medical linear accelerators and intended co assist a licensed practitioner in the delivery of radiation to defined target volumes, (e.g. lesions, arterio-venous malformations, malignant and benign turnours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042794 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042794: Beam Modulator, Model 4513 332 8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042794

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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