Name: Predicase
Price: 199 USD

K-number	K212420
Device name	Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
Applicant	Brainlab AG
Product code	LLZ
Device class	Class II
Decision date	Dec 16, 2021
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

Everything you need for a 510(k) submission. Nothing you don't.