FDA 510(k)

ExacTrac Dynamic 1.1.2

N.º K: K231052 · 2023-05-11

Fecha de decisión2023-05-11

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ExacTrac Dynamic 1.1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K231052. 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 1.1.2?

ExacTrac Dynamic 1.1.2 is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Brainlab AG. The 510(k) number is K231052.

When did ExacTrac Dynamic 1.1.2 receive FDA 510(k) clearance?

ExacTrac Dynamic 1.1.2 received FDA 510(k) clearance on 2023-05-11, under 510(k) number K231052.

Who is the listed applicant for ExacTrac Dynamic 1.1.2?

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

What is the FDA product code for ExacTrac Dynamic 1.1.2?

The FDA product code for ExacTrac Dynamic 1.1.2 is IYE.

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