GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM— 510(k) K113034

Name: FDA 510(k) clearance K113034
Creator: U.S. Food and Drug Administration
Published: 2011-12-13

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K113034 for GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM, Substantially Equivalent on 2011-12-13. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 2011-10-11
Decision date: 2011-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.