# K943224: Varian Multileaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Feb 2, 1996 after 577 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
No predicates in its family tree.
87 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973889: Varian Multileaf Collimator with Dynamic Arc Therapy Feature (1997), 70 descendants of its own
- K990085: Millennium MLC -120 (1999), 69 descendants of its own
- 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

## Recalls of this device
- Jan 16, 2012 · Not classified · Z-1091-2012: When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exce
- Jan 16, 2012 · Not classified · Z-1090-2012: When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exce

Source page: https://510kreport.com/device/K943224
Methodology: https://510kreport.com/methodology