ADVANCED HIP ASSESSMENT SOFTWARE— 510(k) K011917

Name: FDA 510(k) clearance K011917
Creator: U.S. Food and Drug Administration
Published: 2001-08-03

Substantially Equivalent

Ge Lunar Corp.

FDA 510(k) clearance K011917 for ADVANCED HIP ASSESSMENT SOFTWARE, Substantially Equivalent on 2001-08-03. 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: 2001-06-20
Decision date: 2001-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
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 →

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