MRI- FLOW ANALYTICAL SOFTWARE PACKAGE— 510(k) K994282

Substantially Equivalent

Medis Medical Imaging Systems BV

FDA 510(k) clearance K994282 for MRI- FLOW ANALYTICAL SOFTWARE PACKAGE, Substantially Equivalent on 2000-03-02. Applicant: Medis Medical Imaging Systems BV.

Clearance details

Applicant: Medis Medical Imaging Systems BV
Product code: Code LNH
Advisory panel: Radiology
Date received: 1999-12-20
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leiden, NL

Download summary PDF View on FDA.gov ↗

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.