FDA 510(k)

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

N.º K: K254010 · 2026-01-14

Fecha de decisión2026-01-14

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab SE. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K254010. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Brainlab SE. The 510(k) number is K254010.

When did ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface receive FDA 510(k) clearance?

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2026-01-14, under 510(k) number K254010.

Who is the listed applicant for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

The FDA 510(k) record lists Brainlab SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

The FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is IYE.

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