# K040585: Exactrac 4.0 and Exactrac X-Ray 6D

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 11, 2004 after 67 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: 1 generation back to K003285 (2001). 1 ancestor in all.
41 later devices descend from it; 5 cite it directly.
0 of 43 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.

## Most influential descendants
- K072506: Exactrac 5.5 (2007), 15 descendants of its own
- K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem (2007), 13 descendants of its own
- K060906: Calypso 4D Localization System (2006), 11 descendants of its own
- K122451: Exactrac Vero (2012), 10 descendants of its own
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own

## Indications for use
ExacTrac 4.0 is 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 4.0 system uses optical tracking of infrared reflecting markers and x-ray registration as the method of locating the position of the patient.

Source page: https://510kreport.com/device/K040585
Methodology: https://510kreport.com/methodology