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510(k) K253181

SURGIMAGE SIM 1000H Fluorescence Imaging Platform by Surgimage Corporation — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2026
Date Received
September 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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