Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

Brainlab AG · K243633 · 2025-06-13

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K243633) with a decision date of 2025-06-13. Review panel: Radiology.

FDA submission numberK243633
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Radiology
FDA decision date2025-06-13
DecisionSubstantially Equivalent
Product codeQIH
ClassificationAutomated Radiological Image Processing Software
Device class2
Regulation number892.2050
Review time (calendar days)200
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.