510(k) · Cleared
Recalled · 2009M3 (Micro-Multileaf Collimator)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · IYE Accelerator, Linear, Medical
Cleared on Jun 6, 2002 as substantially equivalent to K004022 (Brainlab AG, 2002) after an 80-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K004022 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK004022 M3 (Mirco-Multileaf CollimatorBrainlab AG · 2002 · Recalled
- This deviceK020860 M3 (Micro-Multileaf Collimator)Brainlab AG · 2002
- Descendant · cites it directly · 1 of its ownK060187 Topslane DMLCTopslane International, LLC · 2006
- Descendant · cites it directly · 1 of its ownK052705 DART-12Direx Systems Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK090802 Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK071701 Trackleaf-10Direx Systems Corp. · 2007
Most influential descendants
Showing 4 of 4 · See all- K060187Topslane DMLCTopslane International, LLC · 2006 · cites it directly1descendant
- K052705DART-12Direx Systems Corp. · 2006 · cites it directly1descendant
- K090802Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009 · 2 generations on0descendants
- K071701Trackleaf-10Direx Systems Corp. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K004022 | M3 (Mirco-Multileaf Collimator | Brainlab AG | 2002 | 2 |
| 0 (this device) | K020860 | M3 (Micro-Multileaf Collimator) | Brainlab AG | 2002 | — |
| +1 | K060187 | Topslane DMLC | Topslane International, LLC | 2006 | — |
| +1 | K052705 | DART-12 | Direx Systems Corp. | 2006 | — |
| +2 | K090802 | Tigrt MLC, Tigrt DMLC | Linatech, LLC | 2009 | — |
| +2 | K071701 | Trackleaf-10 | Direx Systems Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K004022 | M3 (Mirco-Multileaf Collimator Cleared while this submission was under review Summary page 1…mmon name: micro-Multi-Leaf Collimator Device Classification name: Accelerator, Linear, Medical 3. Predicate Devices: micro-Multi-Leaf Collimator (K004022) Device Classification Name: Accelerator, Linear, Medical Regulatory Class: Class II 4. Device Description The m3 is a therapeu… | 2002 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2009 | Not classified | Z-1546-2009 | Other | The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The m3 is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is.suitable for static conformal treatments and “step and shoot IMRT”. The advanced m3 Siemens…
Read the full statement (109 words)
The m3 is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In conjunction with Elekta and GE Linacs, the m3 performs the same function as customized shadow blocks or stereotactic collimators. This standard configuration is.suitable for static conformal treatments and “step and shoot IMRT”.
The advanced m3 Siemens Integration feature available for Siemens Linacs allows additionally to perform “dynamic arc” and automated “step and shoot IMRT” treatments with the m3.
The advanced Varian integration feature available for Varian Linacs allows to perform “dynamic arc” and “dynamic IMRT” treatments with the m3.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020860: M3 (Micro-Multileaf Collimator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020860
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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