CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY— 510(k) K063628

Substantially Equivalent

Ge Healthcare Integrated IT Solutions

FDA 510(k) clearance K063628 for CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY, Substantially Equivalent on 2006-12-26. Applicant: Ge Healthcare Integrated IT Solutions.

Clearance details

Applicant: Ge Healthcare Integrated IT Solutions
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-12-06
Decision date: 2006-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrington, IL, US

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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.