# K220338: ExacTrac Dynamic

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 29, 2022 after 81 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963624 (1996). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201276: ExacTrac Dynamic, Brainlab AG (2020) Summary page 4.

## Most influential descendants
- 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, 2023 · Class II · Z-1259-2023: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

## Indications for use
ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K220338
Methodology: https://510kreport.com/methodology