Home / 510(k) Clearances / K243132

510(k) K243132

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2024
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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