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

Name: FDA 510(k) clearance K171977
Creator: U.S. Food and Drug Administration
Published: 2018-08-02

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.. Device class: 2.

Clearance details

Applicant: Hinacom Software and Technology, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
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 ↗

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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.