510(k) K223106 · QIH Automated Radiological Image Processing Software

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, Munich, DE
Decision	Substantially Equivalent, Jul 14, 2023
Received	Sep 30, 2022
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K223106

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.