Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)— 510(k) K172750

Name: FDA 510(k) clearance K172750
Creator: U.S. Food and Drug Administration
Published: 2018-02-28

Substantially Equivalent

Guangzhou Sonostar Technologies Co., Ltd.

FDA 510(k) clearance K172750 for Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe), Substantially Equivalent on 2018-02-28. Applicant: Guangzhou Sonostar Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Sonostar Technologies Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2017-09-12
Decision date: 2018-02-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.