510(k) · Cleared
Recalled · 2012Moduleaf
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 Mar 17, 2003 as substantially equivalent to K011816 (Mrc Systems GmbH, 2001) after a 19-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 17, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- IXI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000349 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000349 Motorized Micro Multileaf CollimatorStryker Leibinger · 2000
- 1 generation backK011816 Mini Multileaf Collimator, Model KmiMrc Systems GmbH · 2001
- This deviceK030609 ModuleafMrc Systems GmbH · 2003
- Descendant · cites it directly · 0 of its ownK042794 Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005
Most influential descendants
Showing 1 of 1 · See all- K042794Beam Modulator, Model 4513 332 8000Elekta, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000349 | Motorized Micro Multileaf Collimator | Stryker Leibinger | 2000 | — |
| −1 | K011816 | Mini Multileaf Collimator, Model Kmi | Mrc Systems GmbH | 2001 | — |
| 0 (this device) | K030609 | Moduleaf | Mrc Systems GmbH | 2003 | — |
| +1 | K042794 | Beam Modulator, Model 4513 332 8000 | Elekta, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K011816 | Mini Multileaf Collimator, Model Kmi | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042794 | Beam Modulator, Model 4513 332 8000 | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2012 | Not classified | Z-1184-2012 | Nonconforming Material/Component | This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042794 (Elekta, Ltd., 2005) has gone furthest, with 0 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 | — |
What is it indicated for?
The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030609: Moduleaf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030609
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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