ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

ExacTrac Dynamic is a patient positioning and monitoring system for radiotherapy that uses X-ray imaging and thermal surface cameras to position patients accurately at the treatment beam of a medical accelerator, monitor patient position during treatment, and provide a beam hold signal if deviation occurs. It is intended for stereotactic radiosurgery and radiotherapy procedures to treat lesions, tumors, and conditions anywhere in the body.

The subject device version 2.0.2 adds compatibility with Elekta EVO linear accelerators via an updated NEMA gating interface, whereas the predicate device 2.0 supported only Varian linacs. Both versions use stereo X-ray imaging, thermal surface cameras, and imported CBCT data for patient localization, with support for breath-hold functionality and surface-only workflows via the ExacTrac Dynamic Surface (ETDS) configuration.

Not stated in this summary.

The subject device is substantially equivalent to the predicate (K240431; ExacTrac Dynamic 2.0) because both share identical indications for use, localization techniques, preparation workflows, user management approaches, and patient feedback features. The primary change is a version update to 2.0.2 for compatibility with Elekta EVO linacs, which is a minor third-digit software revision that does not affect functionality or intended use; software verification testing confirms the change is valid and no additional bench or clinical testing was required.