# K983660: Exactrac (Brainlab Patient Positioning System)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab, Inc.
- Decided: Jul 14, 1999 after 268 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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.
32 later devices descend from it; 3 cite it directly.
0 of 33 devices 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.

## Most influential descendants
- K052682: Alignrt (2006), 18 descendants of its own
- K072171: Gatect-RT (2007), 12 descendants of its own
- K060906: Calypso 4D Localization System (2006), 11 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own
- K123371: Alignrt Plus (2013), 8 descendants of its own

## Indications for use
This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac System uses optical tracking of infrared reflecting markers as the method of locating the position of the patient. The ExacTrac System consists of infrared cameras, computer workstation, reflective markers and calibration tools.

Source page: https://510kreport.com/device/K983660
Methodology: https://510kreport.com/methodology