# K040553: Modification to Acculeaf

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Apr 1, 2004 after 30 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970586 (1997). 2 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K021338: Acculeaf, Direx Systems Corp. (2003) Summary page 2.
- K970586: Brainlab Micro Multi-Leaf Collimator, Brainlab Med. Computersysteme GmbH (1997) Summary page 1.

## Most influential descendants
- K052705: DART-12 (2006), 1 descendant of its own
- K071701: Trackleaf-10 (2007), 0 descendants of its own
- K043409: Accuchanger (2005), 0 descendants of its own

## Indications for use
AccuLeaf 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. In this application AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years.

Source page: https://510kreport.com/device/K040553
Methodology: https://510kreport.com/methodology