# K071701: Trackleaf-10

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Jul 23, 2007 after 32 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 K970586 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052705: DART-12, Direx Systems Corp. (2006) Summary page 2.
- K040553: Modification to Acculeaf, Direx Systems Corp. (2004) Summary page 2.

## Indications for use
TrackLeaf-10 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. TrackLeaf-10 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.

Source page: https://510kreport.com/device/K071701
Methodology: https://510kreport.com/methodology