510(k) · Cleared
ClearedMini Multileaf Collimator, Model Kmi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrc Systems GmbH · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Sep 7, 2001 as substantially equivalent to K000349 (Stryker Leibinger, 2000) after an 88-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Sep 7, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000349 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000349 Motorized Micro Multileaf CollimatorStryker Leibinger · 2000
- This deviceK011816 Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 2001
- Descendant · cites it directly · 1 of its ownK030609 ModuleafMrc Systems GmbH · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK042794 Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000349 | Motorized Micro Multileaf Collimator | Stryker Leibinger | 2000 | — |
| 0 (this device) | K011816 | Mini Multileaf Collimator, Model Kmi | Mrc Systems GmbH | 2001 | — |
| +1 | K030609 | Moduleaf | Mrc Systems GmbH | 2003 | 1 |
| +2 | K042794 | Beam Modulator, Model 4513 332 8000 | Elekta, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K000349 | Motorized Micro Multileaf CollimatorSummary page 1…evices (21 CFR 892.5710, Product Code IXI). Predicate Device The Mini Multileaf Collimator is substantially equivalent to the MRC Motorized Micro Multileaf Collimator (K000349). Device Description The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that is mounted to… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030609 | Moduleaf | 2003 | 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?
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 | — |
What is it indicated for?
The Mini Multileaf Collimator is a conformal radiation therapy and-radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
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/K011816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011816: Mini Multileaf Collimator, Model Kmi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011816
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026