# K122451: Exactrac Vero

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 28, 2012 after 46 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003285 (2001). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072046: Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac Oem, Brainlab AG (2007) Summary page 1.
- K120233: Synchrony Respiratory Tracking System, Accuray Incorporated (2012) Summary page 1.

## Most influential descendants
- 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
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (2022), 1 descendant of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0172-2018: Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may
- May 4, 2016 · Class II · Z-1929-2016: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

## Indications for use
ExacTrac Vero is intended to be used in conjunction with the MHI-TM2000 radiation therapy linear accelerator system manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero 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. ExacTrac Vero 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. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the TM2000 gantry head to the MHI-TM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.

Source page: https://510kreport.com/device/K122451
Methodology: https://510kreport.com/methodology