XIRALITE FLOURESCENCE IMAGING SYSTEM X4— 510(k) K130003

Substantially Equivalent

Mivenion GmbH

FDA 510(k) clearance K130003 for XIRALITE FLOURESCENCE IMAGING SYSTEM X4, Substantially Equivalent on 2014-01-31. Applicant: Mivenion GmbH.

Clearance details

Applicant: Mivenion GmbH
Product code: Code IZI
Advisory panel: Radiology
Date received: 2013-01-02
Decision date: 2014-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.