510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182165Substantially Equivalent

Color Doppler Ultrasound System; Model: mEye1 and mEye2

Shenzhen Well.D Medical Electronics Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182165 is the FDA 510(k) clearance record for Color Doppler Ultrasound System; Model: mEye1 and mEye2, a class II device, cleared for Shenzhen Well.D Medical Electronics Co., Ltd. on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 2 510(k) clearances for Shenzhen Well.D Medical Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K182165.

Clearance record

Decision date
Received
(132 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Shenzhen Well.D Medical Electronics Co., Ltd. Well.D Park, Qinglan 3 Rd., National Biopharmaceutical, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261