# K052705: DART-12

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Feb 21, 2006 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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) Summary page 1.
- K020860: M3 (Micro-Multileaf Collimator), Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K071701: Trackleaf-10 (2007), 0 descendants of its own

## Indications for use
DART-12 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. DART-12 is a tertiay Micro MultLLeaf Collimating (MMLC) system, It performs the same functions as bean-shaping- blocks, -circular or cut blocks collimators for Conformal and t step and shoot iMRTR treatments, and it also performs "dynamicarcs' and 'dynamiclIMRT" treatments.

Source page: https://510kreport.com/device/K052705
Methodology: https://510kreport.com/methodology