# K112613: Integrity (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Dec 16, 2011 after 100 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: 5 generations back to K963624 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102200: Integrity Model 1014284, Elekta, Ltd. (2010) Summary page 1.

## Recalls of this device
- Nov 20, 2017 · Class II · Z-0724-2018: Potential for positional errors following automatic table movement (ATM).
- Nov 25, 2013 · Class II · Z-1083-2014: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
- Mar 28, 2013 · Class II · Z-1322-2014: The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

## Indications for use
IntegrityTM is the interface and control software for the Elekta range of medical digital linear accelerators 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 tumours), 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/K112613
Methodology: https://510kreport.com/methodology