510(k) Report

FDA applicant

Shenzhen Well.D Medical Electronics Co., Ltd.

Shanghai, CN2 decisions2010–20180 recalls

FDA records 2 decisions for Shenzhen Well.D Medical Electronics Co., Ltd. (Shanghai, CN) from 2010 to 2018: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Shenzhen Well.D Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2010: 12018: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Shenzhen Well.D Medical Electronics Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K182165Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd. · 2018
  • K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd. · 2010

All 2 as Shenzhen Well.D Medical Electronics Co., Ltd. →