510(k) K243698 ยท HAW Neurological Stereotaxic Instrument
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, Munich, DE |
| Decision | Substantially Equivalent, Jan 28, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243698
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.