FACT Medical Imaging Sysytem— 510(k) K143586

Substantially Equivalent

Dexin Medical Imaging Technology Co., Ltd.

FDA 510(k) clearance K143586 for FACT Medical Imaging Sysytem, Substantially Equivalent on 2015-09-02. Applicant: Dexin Medical Imaging Technology Co., Ltd..

Clearance details

Applicant: Dexin Medical Imaging Technology Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-12-18
Decision date: 2015-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weinan Hign-Tech Zone, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.