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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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223106
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/14/2023
Days to Decision
287 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223106
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/14/2023
Days to Decision
287 days
Submission Type
Summary