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510(k) K233579

SC1 Handheld Ultrasound Imaging system (Model: SC1) by Fcu Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2024
Date Received
November 7, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Fcu Co., Ltd.

  • K210468 — SC1 Handheld Ultrasound Imaging System (Model: SC1) (July 23, 2021)

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