# K042794: Beam Modulator, Model 4513 332 8000

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Jan 31, 2005 after 116 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: 3 generations back to K926449 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904124: Philips Multileaf Collimator (MLC), Philips Medical Systems, Inc. (1991) Summary page 1.
- K963624: Philips Sli Series Linear Accelerator, Philips Medical Systems, Inc. (1996) Summary page 1.
- K990085: Millennium MLC -120, Varian Assoc., Inc. (1999) Summary page 1.
- K030609: Moduleaf, Mrc Systems GmbH (2003) Summary page 1.

## Indications for use
The Elekta Beam Modulator is an X-ray collimator, designed to be used with the Elckta range of medical linear accelerators and intended co assist a licensed practitioner in the delivery of radiation to defined target volumes, (e.g. lesions, arterio-venous malformations, malignant and benign turnours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.

Source page: https://510kreport.com/device/K042794
Methodology: https://510kreport.com/methodology