# K970586: Brainlab Micro Multi-Leaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab Med. Computersysteme GmbH
- Decided: May 12, 1997 after 87 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
No predicates in its family tree.
79 later devices descend from it; 4 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973889: Varian Multileaf Collimator with Dynamic Arc Therapy Feature (1997), 70 descendants of its own
- K990085: Millennium MLC -120 (1999), 69 descendants of its own
- K050442: Millennium Multi-Leaf Collimator (2005), 67 descendants of its own
- K071992: High-Definition 120 Multileaf Collimator (HD120 MLC) (2007), 64 descendants of its own
- K092871: Trilogy MX (2009), 61 descendants of its own

## Recalls of this device
- Mar 19, 2009 · Not classified · Z-1544-2009: 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/K970586
Methodology: https://510kreport.com/methodology