# K011816: Mini Multileaf Collimator, Model Kmi

- Pathway: 510(k) (Traditional)
- Applicant: Mrc Systems GmbH
- Decided: Sep 7, 2001 after 88 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000349 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000349: Motorized Micro Multileaf Collimator, Stryker Leibinger (2000) Summary page 1.

## Most influential descendants
- K030609: Moduleaf (2003), 1 descendant of its own
- K042794: Beam Modulator, Model 4513 332 8000 (2005), 0 descendants of its own

## Indications for use
The Mini Multileaf Collimator is a conformal radiation therapy and-radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate 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. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.

Source page: https://510kreport.com/device/K011816
Methodology: https://510kreport.com/methodology