FDA applicant

Sonoscape Company Limited

Shenzhen, Guangdong, CN22 decisions2004–20150 recalls

FDA records 22 decisions for Sonoscape Company Limited (Shenzhen, Guangdong, CN) from 2004 to 2015: 22 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 43 predicates, 24 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 Sonoscape Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

4in 2015

2007high 7 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sonoscape Company Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonoscape Company Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Sonoscape”

FDA records each applicant name separately; these may or may not be the same firm.

Sonoscape Medical Corp. 26

Sonoscape Company Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sonoscape”