CEDARA I-SOFTVIEW— 510(k) K022881

Substantially Equivalent

Cedara Software Corp.

FDA 510(k) clearance K022881 for CEDARA I-SOFTVIEW, Substantially Equivalent on 2002-10-22. Applicant: Cedara Software Corp..

Clearance details

Applicant: Cedara Software Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2002-08-30
Decision date: 2002-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

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.