510(k) · Cleared

Cleared

Siemens Beam Shaper

K961902510(k) TraditionalCleared Aug 8, 199684-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 Aug 8, 1996 as substantially equivalent to K953894 (Siemens Medical Solutions USA, Inc., 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Aug 8, 1996
Review: 84 days
Class: Class II
Product code: IXI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953894 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK953894 Siemens Multileaf CollimatorSiemens Medical Solutions USA, Inc. · 1995
This deviceK961902 Siemens Beam ShaperSiemens Medical Solutions USA, Inc. · 1996
Descendant · cites it directly · 0 of its ownK982952 ImfastSiemens Medical Solutions USA, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K982952ImfastSiemens Medical Solutions USA, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953894	Siemens Multileaf Collimator	Siemens Medical Solutions USA, Inc.	1995	—
0 (this device)	K961902	Siemens Beam Shaper	Siemens Medical Solutions USA, Inc.	1996	—
+1	K982952	Imfast	Siemens Medical Solutions USA, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K961902, 1995–1999Source: 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 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? (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
*	K953894	Siemens Multileaf Collimator Summary page 1 …ssification Names: Radiation therapy beam shaping block - 21 CFR § 892.5710 Class II, Product Code: RA 90 IXI Predicate Device: Siemens Multileaf Collimator Hand Control K953894 Description of Device: Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from…	Siemens Medical Solutions USA, Inc.	1995	—

Also cleared against K953894: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982952	Imfast	Siemens Medical Solutions USA, Inc.	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K982952 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K953894.

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	—

What is it indicated for?

The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system.

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/K961902 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961902: Siemens Beam Shaper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961902

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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