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FDA 510(k)

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

N.º K: K243633 · 2025-06-13

SolicitanteBrainlab AG
Fecha de decisión2025-06-13
Código de productoQIH
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K243633. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)?

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Brainlab AG. The 510(k) number is K243633.

When did Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) receive FDA 510(k) clearance?

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) received FDA 510(k) clearance on 2025-06-13, under 510(k) number K243633.

Who is the listed applicant for Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)?

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 Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)?

The FDA product code for Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) is QIH.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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