# K982549: Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Dec 30, 1998 after 162 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K970586 (1997). 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)
- K970586: Brainlab Micro Multi-Leaf Collimator, Brainlab Med. Computersysteme GmbH (1997) Summary page 2.

## Most influential descendants
- K993594: Conformax MMLC VR1 (1999), 1 descendant of its own
- K023519: Radionics Varilink 2 (2003), 0 descendants of its own

## Indications for use
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software or treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.

Source page: https://510kreport.com/device/K982549
Methodology: https://510kreport.com/methodology