510(k) K243698

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT by Brainlab AG — Product Code HAW

K243698 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT". The FDA issued a decision of Substantially Equivalent on January 28, 2025. 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.