miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer— 510(k) K171977

Substantially Equivalent

Hinacom Software and Technology, Ltd.

FDA 510(k) clearance K171977 for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer, Substantially Equivalent on 2018-08-02. Applicant: Hinacom Software and Technology, Ltd..

Clearance details

Applicant: Hinacom Software and Technology, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2017-06-30
Decision date: 2018-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, 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.