# K071992: High-Definition 120 Multileaf Collimator (HD120 MLC)

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems
- Decided: Aug 15, 2007 after 26 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926449 (1995). 6 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050442: Millennium Multi-Leaf Collimator, Varian Medical Systems (2005) Summary page 1.

## Most influential descendants
- 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
- K123808: Agility (2013), 36 descendants of its own
- K140528: True Beam, True Beam STX, Edge (2014), 31 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
- Jun 6, 2011 · Not classified · Z-3052-2011: When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmissi
- Jan 30, 2008 · Not classified · Z-1459-2008: Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.

## Indications for use
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

Source page: https://510kreport.com/device/K071992
Methodology: https://510kreport.com/methodology