CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23— 510(k) K082628

Name: FDA 510(k) clearance K082628
Creator: U.S. Food and Drug Administration
Published: 2008-11-20

Substantially Equivalent

Circle Cardiovascular Imaging, Inc.

FDA 510(k) clearance K082628 for CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23, Substantially Equivalent on 2008-11-20. Applicant: Circle Cardiovascular Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Circle Cardiovascular Imaging, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2008-09-09
Decision date: 2008-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, Alberta, 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.