# K121328: Agility

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Jun 12, 2012 after 40 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963624 (1996). 2 ancestors in all.
37 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)
- K082122: MLCI2, Elekta, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K170817: Halcyon (2017), 15 descendants of its own

## Recalls of this device
- Nov 25, 2013 · Class II · Z-1084-2014: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
- Apr 30, 2013 · Class II · Z-1402-2013: Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
- Jul 27, 2012 · Class II · Z-2340-2012: Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

## Indications for use
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Source page: https://510kreport.com/device/K121328
Methodology: https://510kreport.com/methodology