# K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 17, 2007 after 84 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 K003285 (2001). 2 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040585: Exactrac 4.0 and Exactrac X-Ray 6D, Brainlab AG (2004) Summary page 1.

## Most influential descendants
- K122451: Exactrac Vero (2012), 10 descendants of its own
- K131965: XVI R5.0 (2013), 8 descendants of its own
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (2018), 2 descendants of its own

## Indications for use
The ExacTrac 3rd Party system is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac 3rd Party uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac 3rd Party system uses stereoscopic x-ray or cone beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment.

Source page: https://510kreport.com/device/K072046
Methodology: https://510kreport.com/methodology