GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT— 510(k) K072439

Name: FDA 510(k) clearance K072439
Creator: U.S. Food and Drug Administration
Published: 2007-09-14

Substantially Equivalent

Ge Medical Systems Ultrasound and Primary Care Dia

FDA 510(k) clearance K072439 for GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT, Substantially Equivalent on 2007-09-14. 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: 2007-08-30
Decision date: 2007-09-14
Decision: Substantially Equivalent
Clearance type: Special
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 →

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