Home / 510(k) Clearances / K243698

510(k) K243698

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 by Brainlab AG — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2025
Date Received
November 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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