GE LUNAR VISCERAL FAT SOFTWARE— 510(k) K103730

Name: FDA 510(k) clearance K103730
Creator: U.S. Food and Drug Administration
Published: 2011-05-06

Substantially Equivalent

Ge Medical Systems Ultrasound and Primary Care Dia

FDA 510(k) clearance K103730 for GE LUNAR VISCERAL FAT SOFTWARE, Substantially Equivalent on 2011-05-06. Applicant: Ge Medical Systems Ultrasound and Primary Care Dia. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2010-12-21
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.