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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K212420

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio · Brainlab AG · decided 2021-12-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Brainlab Elements Contouring4.0Brainlab SEJAK LLZ04056481143015
Brainlab Elements Image Fusion Angio1.0Brainlab SEJAK LLZ04056481138530
Brainlab Elements Image Fusion4.0Brainlab SEJAK LLZ04056481140816
Brainlab Elements Fibertracking2.0Brainlab SEJAK LLZ04056481142186