CORONIS 5MP— 510(k) K133984

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K133984 for CORONIS 5MP, Substantially Equivalent on 2014-03-28. Applicant: Barco N.V..

Clearance details

Applicant: Barco N.V.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-12-26
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kortrijk, BE

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.