CS IMAGING— 510(k) K113419

Substantially Equivalent

Trophy

FDA 510(k) clearance K113419 for CS IMAGING, Substantially Equivalent on 2012-02-16. Applicant: Trophy.

Clearance details

Applicant: Trophy
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2011-11-18
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Croissy-Beaubourg, 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.