# K201276: ExacTrac Dynamic

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 13, 2020 after 61 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: 5 generations back to K963624 (1996). 12 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120789: Exactrac X-Ray X-Ray, Brainlab AG (2012) Summary page 4.

## Most influential descendants
- 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
- K211939: ExacTrac Dynamic (2021), 0 descendants of its own

## Recalls of this device
- Mar 1, 2021 · Class II · Z-1185-2021: In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the 

## 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/K201276
Methodology: https://510kreport.com/methodology