K223864
- 510(k) number
- K223864
- Device name
- Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- Applicant
- Brainlab AG DE
- Product code
- HAW — Neurological Stereotaxic Instrument
- Decision date
- 2023-09-09
- Date received
- 2022-12-23
- 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: K223864.pdf
Official FDA record: K223864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.