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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K233579
Device Name SC1 Handheld Ultrasound Imaging system (Model: SC1)
Applicant
Fcu Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-Ro
Yuseong-Gu,  KR 34013
Applicant Contact Song Hyuk
Correspondent
Fcu Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-Ro
Yuseong-Gu,  KR 34013
Correspondent Contact Song Hyuk
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received11/07/2023
Decision Date 06/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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