đź“‹ FDA Reference
exactrac dynamic 2 0 2 exactrac dynamic surface
Brainlab Se
Summary: The ExacTrac Dynamic 2.0 is a medical device used for precise tumor ablation. It is primarily utilized by radiation oncologists for stereotactic radiosurgery and body radiation therapy.
FDA Clearance Information
Pathway
510K
Number
K254010 ↗
Decision Date
January 14, 2026
Product Code
IYE
Device Class
Class 2
Evidence
0 studies
The ExacTrac Dynamic 2.0 by Brainlab SE was cleared via the FDA 510(k) pathway on January 14, 2026. It is classified as a Class 2 device under product code IYE.
What It Is
The ExacTrac Dynamic 2.0 is an advanced image-guided radiation therapy system designed for high precision in tumor targeting. It integrates surface and X-ray imaging to enhance the accuracy of radiation delivery. This device is particularly beneficial in stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT), where precision is critical to minimize damage to surrounding healthy tissues.
Clinical Applications
This device is commonly used in oncology settings, particularly in the treatment of brain and body tumors requiring high precision. Radiation oncologists employ it in both hospital and outpatient settings for procedures like SRS and SBRT. It is suitable for patients with tumors located in sensitive areas where precise targeting is essential to protect adjacent healthy tissues.
Indications for Use
The FDA indications suggest that the ExacTrac Dynamic 2.0 is intended for use in patients requiring precise tumor ablation. It is particularly useful for conditions where stereotactic precision is necessary, such as in brain tumors or small body lesions.
Practical Considerations
The ExacTrac Dynamic 2.0 is compatible with various linear accelerator systems and requires integration with existing imaging technologies. Clinicians should consider the technical setup and training required to optimize its use in their practice.
Related Literature
The linked study focused on the clinical commissioning of the Novalis Tx linear accelerator for SRS and SBRT. It highlighted the importance of comprehensive testing and technical guidelines for successful implementation. Key findings included the necessity of precise calibration and integration of imaging systems. Limitations included the need for ongoing evaluation of clinical outcomes post-implementation.
Frequently Asked Questions
What is ExacTrac Dynamic 2.0 used for?
It is used for precise tumor ablation in stereotactic radiosurgery and body radiation therapy.
What specialties typically use this device?
Radiation oncology is the primary specialty that utilizes this device.
What are the FDA-cleared indications?
It is indicated for use in patients needing precise tumor targeting, such as those with brain or small body tumors.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.