# K004022: M3 (Mirco-Multileaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Mar 26, 2002 after 454 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020860: M3 (Micro-Multileaf Collimator) (2002), 4 descendants of its own
- 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-1547-2009: 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.
- Mar 19, 2009 · Not classified · Z-1545-2009: 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.

Source page: https://510kreport.com/device/K004022
Methodology: https://510kreport.com/methodology