MINXRAY, MODEL HF120/60H POWERPLUS— 510(k) K040046

Name: FDA 510(k) clearance K040046
Creator: U.S. Food and Drug Administration
Published: 2004-02-02

Substantially Equivalent

Minxray, Inc.

FDA 510(k) clearance K040046 for MINXRAY, MODEL HF120/60H POWERPLUS, Substantially Equivalent on 2004-02-02. Applicant: Minxray, Inc.. Device class: 2.

Clearance details

Applicant: Minxray, Inc.
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2004-01-12
Decision date: 2004-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.