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

Brainlab AG · K223106 · 2023-07-14

Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K223106) with a decision date of 2023-07-14. Review panel: Radiology.

FDA submission numberK223106
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Radiology
FDA decision date2023-07-14
DecisionSubstantially Equivalent
Product codeQIH
ClassificationAutomated Radiological Image Processing Software
Device class2
Regulation number892.2050
Review time (calendar days)287
Applicant countryDE

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.