510(k) K252709

Wireless Probe Type Ultrasound Scanner by Xuzhou Yongkang Electronic Science Technology Co., Ltd. — Product Code IYN

K252709 is an FDA 510(k) premarket notification submitted by Xuzhou Yongkang Electronic Science Technology Co., Ltd. for the device "Wireless Probe Type Ultrasound Scanner". The FDA issued a decision of Substantially Equivalent on April 2, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Xuzhou Yongkang Electronic Science Technology Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
August 27, 2025
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