# K043409: Accuchanger

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: May 5, 2005 after 146 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 K970586 (1997). 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)
- K040553: Modification to Acculeaf, Direx Systems Corp. (2004)
- K010065: Cranial Stereotactic Equipment, Arplay Medical S.A. (2002)
- K912630: Xknife Radiosurgery System, Rsa, Inc. (1991) Summary page 1.

## Indications for use
AccuChanger is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for the collimation of megavoltage photon beams in conjunction with Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments.

Source page: https://510kreport.com/device/K043409
Methodology: https://510kreport.com/methodology