# K211939: ExacTrac Dynamic

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Jul 22, 2021 after 29 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.
No later device cites it as a predicate yet.
0 of 14 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.

## Recalls of this device
- Feb 25, 2022 · Class II · Z-0733-2022: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

## 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 deviations in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K211939
Methodology: https://510kreport.com/methodology