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510(k) K210468

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2021
Date Received
February 16, 2021
Clearance Type
Traditional
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.

  • K233579 — SC1 Handheld Ultrasound Imaging system (Model: SC1) (June 26, 2024)

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