# K030609: Moduleaf

- Pathway: 510(k) (Special)
- Applicant: Mrc Systems GmbH
- Decided: Mar 17, 2003 after 19 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- 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: 2 generations back to K000349 (2000). 2 ancestors in all.
1 later device descends 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)
- K011816: Mini Multileaf Collimator, Model Kmi, Mrc Systems GmbH (2001)

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

## Recalls of this device
- Feb 7, 2012 · Not classified · Z-1184-2012: This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.

## Indications for use
The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the 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.

Source page: https://510kreport.com/device/K030609
Methodology: https://510kreport.com/methodology