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

About This 510(k) Submission

K243698 is an FDA 510(k) clearance for the 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, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on January 28, 2025, 60 days after receiving the submission on November 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.