# K990085: Millennium MLC -120

- Pathway: 510(k) (Special)
- Applicant: Varian Assoc., Inc.
- Decided: Feb 8, 1999 after 28 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926449 (1995). 4 ancestors in all.
69 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973889: Varian Multileaf Collimator with Dynamic Arc Therapy Feature, Varian Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K111106: Truebeam (2011), 43 descendants of its own
- K123291: Truebeam (2012), 37 descendants of its own

## Recalls of this device
- Nov 10, 2011 · Not classified · Z-0945-2012: Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 witho
- May 27, 2004 · Not classified · Z-1084-04: An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1

## Indications for use
The Varian Millennium 120 Multileaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac® dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

Source page: https://510kreport.com/device/K990085
Methodology: https://510kreport.com/methodology