# K021338: Acculeaf

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Jan 7, 2003 after 256 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: 1 generation back to K970586 (1997). 1 ancestor in all.
4 later devices descend 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)
- K970586: Brainlab Micro Multi-Leaf Collimator, Brainlab Med. Computersysteme GmbH (1997) Summary page 2.

## Most influential descendants
- K040553: Modification to Acculeaf (2004), 3 descendants of its own
- 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
The AccuLeuf is intended to assr&the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The Accukufenables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeuf 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/K021338
Methodology: https://510kreport.com/methodology