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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K253217
Device Name MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Applicant
Medimaging Integrated Solution, Inc (Miis)
3f, # 24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact Sandy Chou
Correspondent
Medimaging Integrated Solution, Inc (Miis)
3f, # 24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact Sandy Chou
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/29/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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