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510(k) K243142

Cranial 4Pi Immobilization by Brainlab AG — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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