FDA 510(k)

Cranial 4Pi Immobilization

N.º K: K243142 · 2025-06-23

Fecha de decisión2025-06-23

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cranial 4Pi Immobilization is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K243142. 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 Cranial 4Pi Immobilization?

Cranial 4Pi Immobilization is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Brainlab AG. The 510(k) number is K243142.

When did Cranial 4Pi Immobilization receive FDA 510(k) clearance?

Cranial 4Pi Immobilization received FDA 510(k) clearance on 2025-06-23, under 510(k) number K243142.

Who is the listed applicant for Cranial 4Pi Immobilization?

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 Cranial 4Pi Immobilization?

The FDA product code for Cranial 4Pi Immobilization is IYE.

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Otros registros que enlistan a Brainlab AG como solicitante

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