DPX SERIES BRAVO DUO BONE DENSITOMETER— 510(k) K030962

Name: FDA 510(k) clearance K030962
Creator: U.S. Food and Drug Administration
Published: 2003-07-25

Substantially Equivalent

Ge Lunar Corp.

FDA 510(k) clearance K030962 for DPX SERIES BRAVO DUO BONE DENSITOMETER, Substantially Equivalent on 2003-07-25. Applicant: Ge Lunar Corp.. Device class: 2.

Clearance details

Applicant: Ge Lunar Corp.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2003-03-27
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGI

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More clearances from Ge Lunar Corp.

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K023554 — DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE2002-12-20
K011917 — ADVANCED HIP ASSESSMENT SOFTWARE2001-08-03

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 K030962

K-number listed on FDA's recall record

Z-1393-2018 — GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.Class II·Terminated·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·20180316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030962.

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