CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER— 510(k) K002590

Name: FDA 510(k) clearance K002590
Creator: U.S. Food and Drug Administration
Published: 2000-10-31

Substantially Equivalent

Cedara Software Corp.

FDA 510(k) clearance K002590 for CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER, Substantially Equivalent on 2000-10-31. Applicant: Cedara Software Corp.. Device class: 2.

Clearance details

Applicant: Cedara Software Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2000-08-21
Decision date: 2000-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Cedara Software Corp.

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K092915 — CEDARA WEBACCESS, MODEL: 2.42010-06-23
K053301 — CEDARA I-RESPONSE CEDARA PET/CT2006-02-03
K040468 — CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO2004-04-23
K022881 — CEDARA I-SOFTVIEW2002-10-22

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.