# K123808: Agility

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Apr 4, 2013 after 114 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: 7 generations back to K926449 (1995). 29 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121328: Agility, Elekta, Ltd. (2012) Summary page 1.
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.
- K111106: Truebeam, Varian Medical Systems, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K181032: Halcyon (2018), 14 descendants of its own

## Recalls of this device
- Nov 20, 2017 · Class II · Z-0723-2018: Potential for positional errors following automatic table movement (ATM).
- Nov 25, 2013 · Class II · Z-1085-2014: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

## 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 R3.1I 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. Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated. The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell, carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SERT, prostate, and bone metastases.

Source page: https://510kreport.com/device/K123808
Methodology: https://510kreport.com/methodology