SENOGRAPH DS, SENOGRAPH ESSENSTIAL— 510(k) K103485

Substantially Equivalent

General Electric Company

FDA 510(k) clearance K103485 for SENOGRAPH DS, SENOGRAPH ESSENSTIAL, Substantially Equivalent on 2011-10-06. Applicant: General Electric Company.

Clearance details

Applicant: General Electric Company
Product code: Code MUE
Advisory panel: Radiology
Date received: 2010-11-26
Decision date: 2011-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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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.