Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Brainlab AG · K223552 · 2023-04-19

Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K223552) with a decision date of 2023-04-19. Review panel: Neurology.

FDA submission numberK223552
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Neurology
FDA decision date2023-04-19
DecisionSubstantially Equivalent
Product codeHAW
ClassificationNeurological Stereotaxic Instrument
Device class2
Regulation number882.4560
Review time (calendar days)145
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.