510(k) · Cleared

Cleared

Siemens Multileaf Collimator

K953894510(k) TraditionalCleared Nov 13, 199588-day reviewClass II21 CFR 892.5710

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

Siemens Medical Solutions USA, Inc. · IXI Block, Beam-Shaping, Radiation Therapy

Cleared on Nov 13, 1995 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided: Nov 13, 1995
Review: 88 days
Class: Class II
Product code: IXI
Recalls: None
Predicates: 0

19 later devices descend from it, 2 citing it directly.

This deviceK953894 Siemens Multileaf CollimatorSiemens Medical Solutions USA, Inc. · 1995
Descendant · cites it directly · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
Descendant · 2 generations on · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
Descendant · 3 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
Descendant · 3 generations on · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
Descendant · 3 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1996high 4 (2009) · low 0 (1997)2026

Most influential descendants

Showing 5 of 19 · See all

K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · cites it directly16descendants
K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on13descendants
K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 3 generations on11descendants
K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on9descendants
K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953894	Siemens Multileaf Collimator	Siemens Medical Solutions USA, Inc.	1995	—
+1	K031764	Oncor Avant-Garde with Coherence Workspaces	Siemens Medical Solutions USA, Inc.	2003	17
+2	K060226	Oncor Expression	Siemens Medical Solutions USA, Inc.	2006	72
+3	K072485	Artiste MV SA	Siemens Medical Solutions USA, Inc.	2007	24
+3	K082775	Prescision Option	Siemens Medical Solutions USA, Inc.	2009	—
+3	K090683	Syngo RT Therapist Connect	Siemens Medical Solutions USA, Inc.	2009	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0
2003	1	0
2005	1	0
2006	2	0
2007	1	0
2009	4	0
2010	2	0
2011	1	0
2012	1	0
2013	1	0
2014	2	0
2018	1	0

FIG. 1 — Lineage of K953894, 1995–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXI? 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 IXI device

#1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K031764	Oncor Avant-Garde with Coherence Workspaces	Siemens Medical Solutions USA, Inc.	2003	16
K961902	Siemens Beam Shaper	Siemens Medical Solutions USA, Inc.	1996	1

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?

Of its descendants, K031764 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 16 descendants of its own.

How does its category compare?

All IXI devices

IXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXI

2in 2022

2007high 3 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXI

90in 2013

2007high 90 (2013) · low 78 (2009)2026

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

Recalls per year · IXI

2in 2013

2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · IXI

1in 2016

2007high 28 (2011) · low 0 (2007)2025

MAUDE reports naming product code IXI, 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	2	—	0	0
2008	0	—	1	0
2009	3	78	0	0
2010	0	—	0	1
2011	2	—	1	28
2012	1	—	1	3
2013	3	90	2	2
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	2	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	1	—	0	—

https://510kreport.com/device/K953894 · printed Nov 5, 2026

Cite this page

510(k) Report. “K953894: Siemens Multileaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953894

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026