ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
FDA 510(k) K254010 · Brainlab SE
510(k) numberK254010
Submission
- Device name
- ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- Applicant
- Brainlab SE
Munich, DE - Received
- December 15, 2025
- Decision date
- January 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface cleared by the FDA?
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010) received a 510(k) decision of Substantially Equivalent on January 14, 2026, 30 days after the submission was received.
What is the product code of K254010?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.