K192079

Substantially Equivalent

EOSedge

Applicant: Eos Imaging
Product code: KPR
Advisory panel: Radiology
Date received: 2019-08-02
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.