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Alignment System Cranial, with Alignment Software Cranial with LITT +4 more mod…
FDA 510(k)Class II (US FDA 510(k))
510(k) K243698
by Brainlab AG
Identifiers
- 510(k) Number
- K243698 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
- Models / Variants
- Cirq Alignment Software Cranial Biopsy FDA 510(k)Cirq Alignment Software Cranial sEEG FDA 510(k)VarioGuide Alignment Software Cranial FDA 510(k)Cirq Alignment Software Cranial LITT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Alignment System Cranial, with Alignment Software Cranial with LITT +4 more mod… by Brainlab AG — Class II — FDA_510K — listed in FDA 510(k) — 5 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243698 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K243698 24 fields · synced Jun 18, 2026