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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K234113
Device Name MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
Applicant
Medimaging Integrated Solution, Inc (Miis)
Industry E. Rd. Iv, Hsinchu Science Park,
Hsinchu, R.O.C. 3f., #24-2
Hsinchu,  TW 30077
Applicant Contact Sandy Chou
Correspondent
Medimaging Integrated Solution, Inc (Miis)
Industry E. Rd. Iv, Hsinchu Science Park,
Hsinchu, R.O.C. 3f., #24-2
Hsinchu,  TW 30077
Correspondent Contact Sandy Chou
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
LMD  
Date Received12/27/2023
Decision Date 05/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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