K052581

Substantially Equivalent

LUNAR IDXA

Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
Product code: KGI
Advisory panel: Radiology
Date received: 2005-09-20
Decision date: 2005-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

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.