510(k) · Cleared

Recalled · 2011

Elekta Synergy System

K032996510(k) SpecialCleared Oct 23, 200328-day reviewClass II21 CFR 892.5050Recalls 3

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

Elekta Oncology Systems, Ltd. · IYE Accelerator, Linear, Medical

Cleared on Oct 23, 2003 as substantially equivalent to K963624 (Philips Medical Systems, Inc., 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996. 85 later devices descend from it. It has been recalled 3 times.

Decided: Oct 23, 2003
Review: 28 days
Class: Class II
Product code: IYE
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K963624 (1996). 85 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
This deviceK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003
Descendant · cites it directly · 79 of its ownK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
Descendant · 2 generations on · 76 of its ownK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · 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
Descendant · 5 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2004high 11 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 85 · See all

K040192ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · cites it directly79descendants
K042720ON-Board Imager DeviceVarian Medical Systems · 2004 · 2 generations on76descendants
K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 3 generations on61descendants
K111106TruebeamVarian Medical Systems, Inc. · 2011 · 4 generations on43descendants
K123291TruebeamVarian Medical Systems, Inc. · 2012 · 5 generations on37descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963624	Philips Sli Series Linear Accelerator	Philips Medical Systems, Inc.	1996	2
0 (this device)	K032996	Elekta Synergy System	Elekta Oncology Systems, Ltd.	2003	—
+1	K040192	ON-Board Imager Device	Varian Medical Systems, Inc.	2004	2
+2	K042720	ON-Board Imager Device	Varian Medical Systems	2004	5
+3	K092871	Trilogy MX	Varian Medical Systems, Inc.	2009	5
+4	K111106	Truebeam	Varian Medical Systems, Inc.	2011	5
+5	K123291	Truebeam	Varian Medical Systems, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	1	0
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	3	0
2013	3	0
2014	3	0
2015	3	0
2016	2	0
2017	7	0
2018	5	0
2019	5	0
2020	5	0
2021	8	0
2022	6	0
2023	11	0
2024	3	0
2025	2	0
2026	7	0

FIG. 1 — Lineage of K032996, 1996–2026Source: 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
*	K963624	Philips Sli Series Linear Accelerator Summary page 1 …The Elekta Synergy"'MSystem is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SLISLi Series, D.C. K963624) and its commercially available options. These devices have an established and proven track record for safety. The primary…	Philips Medical Systems, Inc.	1996	2

Also cleared against K963624: 3 other devices →

What descends from it? (85)

See all 85

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

Number	Device	Applicant	Decided	Descendants
K040192	ON-Board Imager Device	Varian Medical Systems, Inc.	2004	79
K051932	Elekta Synergy; Elekta Synergy S and XVIR3.5	Elekta, Inc.	2005	17
K101038	Rad II Simulator, Rad II KV Imager, Dual Rad II KV Imager	Acceletronics Digital Imaging, LLC	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 6, 2011	Not classified	Z-3079-2011	Other	A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
Mar 18, 2008	Not classified	Z-1441-2010	Finished device change control	Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
Oct 1, 2005	Not classified	Z-1159-2010	Device Design	Customer reported larger than expected variations in wedge factory with gantry rotation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K040192 (Varian Medical Systems, Inc., 2004) has gone furthest, with 79 descendants of its own.
3 other devices also cite its predicate K963624.

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 Synergym System is intended to be used for radiation therapy treatment of malignant neophstic diseases, as determinedby a licensed medical practitioner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032996 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032996: Elekta Synergy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032996

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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