Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Brainlab AG · K223288 · 2023-07-21

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K223288) with a decision date of 2023-07-21. Review panel: Neurology.

FDA submission numberK223288
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Neurology
FDA decision date2023-07-21
DecisionSubstantially Equivalent
Product codeHAW
ClassificationNeurological Stereotaxic Instrument
Device class2
Regulation number882.4560
Review time (calendar days)269
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.