PADSCAN HD SERIES BLADDER SCANNER— 510(k) K131227

Name: FDA 510(k) clearance K131227
Creator: U.S. Food and Drug Administration
Published: 2013-07-12

Substantially Equivalent

Carenoso Technology Co., Ltd.

FDA 510(k) clearance K131227 for PADSCAN HD SERIES BLADDER SCANNER, Substantially Equivalent on 2013-07-12. Applicant: Carenoso Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Carenoso Technology Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2013-04-30
Decision date: 2013-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dandong, Liaoning, 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.