CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION— 510(k) K042525

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K042525 for CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION, Substantially Equivalent on 2004-10-01. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-09-17
Decision date: 2004-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Prospect, 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.