CEDARA I-RESPONSE CEDARA PET/CT— 510(k) K053301

Name: FDA 510(k) clearance K053301
Creator: U.S. Food and Drug Administration
Published: 2006-02-03

Substantially Equivalent

Cedara Software Corp.

FDA 510(k) clearance K053301 for CEDARA I-RESPONSE CEDARA PET/CT, Substantially Equivalent on 2006-02-03. 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: 2005-11-28
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.