K243698
- 510(k) number
- K243698
- Device name
- 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
- Applicant
- Brainlab AG DE
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2025-01-28
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243698.pdf
Official FDA record: K243698
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.