# K111676: APEX

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Sep 30, 2011 after 107 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- 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 K001163 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001163: DMLC IV-Ergo, 3D Line USA, Inc. (2000) Summary page 1.

## Recalls of this device
- Jan 18, 2013 · Class II · Z-0885-2013: If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

## Indications for use
Apex Is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.

Source page: https://510kreport.com/device/K111676
Methodology: https://510kreport.com/methodology