Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

Brainlab AG · K223864 · 2023-09-09

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial is an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K223864) with a decision date of 2023-09-09. Review panel: Neurology.

FDA submission numberK223864
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Neurology
FDA decision date2023-09-09
DecisionSubstantially Equivalent
Product codeHAW
ClassificationNeurological Stereotaxic Instrument
Device class2
Regulation number882.4560
Review time (calendar days)260
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.