# K033287: Exactrac Gating

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 19, 2003 after 66 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: 2 generations back to K864886 (1987). 3 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003285: Exac Trac 2.0 (Novalis Body Module), Brainlab AG (2001) Summary page 1.
- K983629: RPM Respiratory Gating System, Varian Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K072506: Exactrac 5.5 (2007), 15 descendants of its own
- K120789: Exactrac X-Ray X-Ray (2012), 8 descendants of its own
- K201276: ExacTrac Dynamic (2020), 6 descendants of its own
- K080742: Verisuite 1.6, Verisuite-Particle 1.6 (2008), 5 descendants of its own
- K220338: ExacTrac Dynamic (2022), 3 descendants of its own

## Indications for use
The ExacTrac gating module is an extension to the ExacTrac patient positioning system. ExacTrac Gating repositions the patient relative to the treatment machine according to breathing induced shifts of a target area, and controls the gating of the treatment beam.

Source page: https://510kreport.com/device/K033287
Methodology: https://510kreport.com/methodology