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Alignment System Cranial, with Alignment Software Cranial with LITT - Alignment System Cranial, with Alignment Software Cranial with LITT
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
- Alignment System Cranial, with Alignment Software Cranial with LITT FDA 510(k)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 - Alignment System Cranial, with Alignment Software Cranial with LITT by Brainlab AG…
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