Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)— 510(k) K171528

Substantially Equivalent

Avantsonic Technology Co., Ltd.

FDA 510(k) clearance K171528 for Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5), Substantially Equivalent on 2018-01-24. Applicant: Avantsonic Technology Co., Ltd..

Clearance details

Applicant: Avantsonic Technology Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2017-05-25
Decision date: 2018-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

Download summary PDF View on FDA.gov ↗

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.