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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K253181
Device Name SURGIMAGE SIM 1000H Fluorescence Imaging Platform
Applicant
Surgimage Corporation
4f., # 183, # 185, #187, No 189,4f.-1, # 185,
5f.,# 183,# 185,#187,#189,5f.-1,# 185, Gangqian Rd.
Taipei City,  TW 11494
Applicant Contact Vince Chen
Correspondent
Surgimage Corporation
4f., # 183, # 185, #187, No 189,4f.-1, # 185,
5f.,# 183,# 185,#187,#189,5f.-1,# 185, Gangqian Rd.
Taipei City,  TW 11494
Correspondent Contact Vince Chen
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/26/2025
Decision Date 05/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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