FDA 510(k)

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine

Numéro K : K223553 · 2023-08-02

Date de décision2023-08-02

Code produitOLO

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K223553. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Brainlab AG. The 510(k) number is K223553.

When did Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine receive FDA 510(k) clearance?

Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223553.

Who is the listed applicant for Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

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 Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine?

The FDA product code for Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine is OLO.

Essais cliniques associés

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Autres dossiers indiquant Brainlab AG en tant que demandeur

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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Dispositifs connexes (Code : OLO)

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Source officielle

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