# K032790: Micromlc

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 2, 2003 after 24 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC 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 assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs. The Siemens Medical Solutions Oncology Care Systems, microMLC. is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Source page: https://510kreport.com/device/K032790
Methodology: https://510kreport.com/methodology