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510(k) K260792

AerFrame Patient Immobilization System (AFPIS) by Stabilix, LLC — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
March 11, 2026
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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