Name: Predicase
Price: 199 USD

K-number	K223106
Device name	Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Applicant	Brainlab AG
Product code	QIH
Device class	Class II
Decision date	Jul 14, 2023
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

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