CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO— 510(k) K040468

Substantially Equivalent

Cedara Software Corp.

FDA 510(k) clearance K040468 for CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO, Substantially Equivalent on 2004-04-23. Applicant: Cedara Software Corp..

Clearance details

Applicant: Cedara Software Corp.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-02-24
Decision date: 2004-04-23
Decision: Substantially Equivalent
Clearance type: Special
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.