FDA 510(k)

Mixed Reality Spine Navigation

Número K: K242569 · 2025-05-16

Data da decisão2025-05-16

Código do produtoSBF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mixed Reality Spine Navigation is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K242569. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mixed Reality Spine Navigation?

Mixed Reality Spine Navigation is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Brainlab AG. The 510(k) number is K242569.

When did Mixed Reality Spine Navigation receive FDA 510(k) clearance?

Mixed Reality Spine Navigation received FDA 510(k) clearance on 2025-05-16, under 510(k) number K242569.

Who is the listed applicant for Mixed Reality Spine Navigation?

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 Mixed Reality Spine Navigation?

The FDA product code for Mixed Reality Spine Navigation is SBF.

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Outros registros que listam Brainlab AG como candidato(a)

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562Spine & Trauma Navigation Instruments K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD 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)

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