FDA 510(k)

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

N.º K: K243432 · 2025-07-22

Fecha de decisión2025-07-22

Código de productoOWB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243432. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Brainlab AG. The 510(k) number is K243432.

When did Vascular Navigation PAD 2.0; Navigation Software Vascular PAD receive FDA 510(k) clearance?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243432.

Who is the listed applicant for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

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 Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

The FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is OWB.

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Otros registros que enlistan a Brainlab AG como solicitante

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562Spine & Trauma Navigation Instruments K243142Cranial 4Pi Immobilization K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT K243633Brainlab 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)K242569Mixed Reality Spine Navigation

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Fuente oficial

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