K243698 is an FDA 510(k) clearance for the Alignment System Cranial, with Alignment Software Cranial with LITT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K243698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2024 |
| Decision Date | January 28, 2025 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |