PACSMATE, MODEL MMD-4300C/MMD-4300CX— 510(k) K091687

Name: FDA 510(k) clearance K091687
Creator: U.S. Food and Drug Administration
Published: 2009-07-07

Substantially Equivalent

Iei Technology Corp.

FDA 510(k) clearance K091687 for PACSMATE, MODEL MMD-4300C/MMD-4300CX, Substantially Equivalent on 2009-07-07. Applicant: Iei Technology Corp.. Device class: 2.

Clearance details

Applicant: Iei Technology Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2009-06-10
Decision date: 2009-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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K082496 — PACSMATE MMD-3213M MONITOR2008-09-09

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.