QCU ANALYTICAL SOFTWARE PACKAGE— 510(k) K011582

Substantially Equivalent

Medis Medical Imaging Systems BV

FDA 510(k) clearance K011582 for QCU ANALYTICAL SOFTWARE PACKAGE, Substantially Equivalent on 2001-07-31. Applicant: Medis Medical Imaging Systems BV.

Clearance details

Applicant: Medis Medical Imaging Systems BV
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2001-05-23
Decision date: 2001-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leiden, NL

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.