# K072529: Trackport

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Oct 26, 2007 after 49 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

Source page: https://510kreport.com/device/K072529
Methodology: https://510kreport.com/methodology