# K020860: M3 (Micro-Multileaf Collimator)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 6, 2002 after 80 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K004022 (2002). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004022: M3 (Mirco-Multileaf Collimator, Brainlab AG (2002). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K060187: Topslane DMLC (2006), 1 descendant of its own
- K052705: DART-12 (2006), 1 descendant of its own
- K090802: Tigrt MLC, Tigrt DMLC (2009), 0 descendants of its own
- K071701: Trackleaf-10 (2007), 0 descendants of its own

## Recalls of this device
- Mar 19, 2009 · Not classified · Z-1546-2009: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K020860
Methodology: https://510kreport.com/methodology