DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS— 510(k) K031991

Name: FDA 510(k) clearance K031991
Creator: U.S. Food and Drug Administration
Published: 2003-07-30

Substantially Equivalent

Image Analysis, Inc.

FDA 510(k) clearance K031991 for DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS, Substantially Equivalent on 2003-07-30. Applicant: Image Analysis, Inc.. Device class: 2.

Clearance details

Applicant: Image Analysis, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 2003-06-27
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, KY, 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 →

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