# K082122: MLCI2

- Pathway: 510(k) (Special)
- Applicant: Elekta, Ltd.
- Decided: Aug 29, 2008 after 32 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963624 (1996). 1 ancestor in all.
38 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963624: Philips Sli Series Linear Accelerator, Philips Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K121328: Agility (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
- K143224: TrueBeam-TrueBeam STx-Edge (2014), 25 descendants of its own
- K162472: TrueBeam-TrueBeam STx-Edge (2017), 23 descendants of its own

## Recalls of this device
- Apr 19, 2012 · Not classified · Z-1651-2012: The Y2 diaphragm block was found loose.

## Indications for use
The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Source page: https://510kreport.com/device/K082122
Methodology: https://510kreport.com/methodology