FDA 510(k)

RT Elements (4.0)

N.º K: K223279 · 2023-03-14

Fecha de decisión2023-03-14

Código de productoMUJ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

RT Elements (4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223279. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RT Elements (4.0)?

RT Elements (4.0) is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Brainlab AG. The 510(k) number is K223279.

When did RT Elements (4.0) receive FDA 510(k) clearance?

RT Elements (4.0) received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223279.

Who is the listed applicant for RT Elements (4.0)?

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 RT Elements (4.0)?

The FDA product code for RT Elements (4.0) is MUJ.

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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 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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Fuente oficial

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