# K120789: Exactrac X-Ray X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 14, 2012 after 152 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963624 (1996). 11 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K072506: Exactrac 5.5, Brainlab AG (2007) Summary page 1.
- K042720: ON-Board Imager Device, Varian Medical Systems (2004) Summary page 1.

## Most influential descendants
- K201276: ExacTrac Dynamic (2020), 6 descendants of its own
- K220338: ExacTrac Dynamic (2022), 3 descendants of its own
- K240431: ExacTrac Dynamic  (2.0); ExacTrac Dynamic Surface (2024), 1 descendant of its own
- K254010: ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (2026), 0 descendants of its own
- K231052: ExacTrac Dynamic 1.1.2 (2023), 0 descendants of its own

## Recalls of this device
- Feb 14, 2018 · Class II · Z-1006-2018: The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) a
- Aug 5, 2015 · Class II · Z-2440-2015: ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
- Mar 6, 2015 · Class II · Z-1582-2015: ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
- Feb 16, 2015 · Class II · Z-1316-2015: The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
- Jun 24, 2014 · Class II · Z-2146-2014: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite d
- Feb 24, 2014 · Class II · Z-1513-2014: When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility th

## Indications for use
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Source page: https://510kreport.com/device/K120789
Methodology: https://510kreport.com/methodology