# K102200: Integrity Model 1014284

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Nov 4, 2010 after 92 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963624 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080585: Desktop Pro, Elekta, Ltd. (2008) Summary page 1.

## Most influential descendants
- K112613: Integrity (TM) (2011), 0 descendants of its own

## Indications for use
Integrity TM 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/K102200
Methodology: https://510kreport.com/methodology