QPLAQUE MR— 510(k) K073156

Name: FDA 510(k) clearance K073156
Creator: U.S. Food and Drug Administration
Published: 2008-03-04

Substantially Equivalent

Medis Medical Imaging Systems BV

FDA 510(k) clearance K073156 for QPLAQUE MR, Substantially Equivalent on 2008-03-04. Applicant: Medis Medical Imaging Systems BV. Device class: 2.

Clearance details

Applicant: Medis Medical Imaging Systems BV
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2007-11-08
Decision date: 2008-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leiden, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.