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510(k) K254010

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface by Brainlab SE — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2026
Date Received
December 15, 2025
Clearance Type
Special
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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