LUNAR IDXA— 510(k) K052581

Name: FDA 510(k) clearance K052581
Creator: U.S. Food and Drug Administration
Published: 2005-10-20

Substantially Equivalent

Ge Medical Systems Ultrasound and Primary Care Dia

FDA 510(k) clearance K052581 for LUNAR IDXA, Substantially Equivalent on 2005-10-20. 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: 2005-09-20
Decision date: 2005-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K052581

K-number listed on FDA's recall record

Z-1709-2020 — Lunar iDXA bone densitometerClass II·Ongoing·GE Healthcare, LLC·20191203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052581.

Data sourced from openFDA. This site is unofficial and independent of the FDA.