SENOGRAPHE DS, SENOGRAPHE ESSENTIAL— 510(k) K110798

Name: FDA 510(k) clearance K110798
Creator: U.S. Food and Drug Administration
Published: 2011-12-22

Substantially Equivalent

General Electric Company

FDA 510(k) clearance K110798 for SENOGRAPHE DS, SENOGRAPHE ESSENTIAL, Substantially Equivalent on 2011-12-22. Applicant: General Electric Company. Device class: 2.

Clearance details

Applicant: General Electric Company
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2011-03-22
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.