IMAGYS— 510(k) K102000

Substantially Equivalent

Keosys Sas

FDA 510(k) clearance K102000 for IMAGYS, Substantially Equivalent on 2010-10-12. Applicant: Keosys Sas.

Clearance details

Applicant: Keosys Sas
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-07-15
Decision date: 2010-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Herblain, FR

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.