510(k) · Cleared
ClearedMotorized Micro Multileaf Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on May 3, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 3, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK000349 Motorized Micro Multileaf CollimatorStryker Leibinger · 2000
- Descendant · cites it directly · 2 of its ownK011816 Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 2001
- Descendant · 2 generations on · 1 of its ownK030609 ModuleafMrc Systems GmbH · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK042794 Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK032790 MicromlcSiemens Medical Solutions USA, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K011816Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 2001 · cites it directly2descendants
- K030609ModuleafMrc Systems GmbH · 2003 · 2 generations on1descendant
- K042794Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005 · 3 generations on0descendants
- K032790MicromlcSiemens Medical Solutions USA, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000349 | Motorized Micro Multileaf Collimator | Stryker Leibinger | 2000 | — |
| +1 | K011816 | Mini Multileaf Collimator, Model Kmi | Mrc Systems GmbH | 2001 | — |
| +2 | K030609 | Moduleaf | Mrc Systems GmbH | 2003 | 1 |
| +3 | K042794 | Beam Modulator, Model 4513 332 8000 | Elekta, Ltd. | 2005 | — |
| +1 | K032790 | Micromlc | Siemens Medical Solutions USA, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
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
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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K011816 (Mrc Systems GmbH, 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
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/K000349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000349: Motorized Micro Multileaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000349
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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