510(k) K223864

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial by Brainlab AG — Product Code HAW

K223864 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial". The FDA issued a decision of Substantially Equivalent on September 9, 2023. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Brainlab AG has at least 10 other 510(k) clearances on record.