Cleared Special

K031991 - DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS

K031991 is an FDA 510(k) clearance for DXAVIEW SPINE AND HIP, manufactured by Image Analysis, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Special 510(k) pathway after a 33-day FDA review.

K031991 · Image Analysis, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
33d
Days
Class 2
Risk

K031991 is an FDA 510(k) clearance for the DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Image Analysis, Inc. (Columbia, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031991

510(k) Number K031991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date July 30, 2003
Days to Decision 33 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

KGI Device Classification - Class 2, Special Controls

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KGI Densitometer, Bone

All 138
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K031991.
PEDIATRIC REFERENCE DATABASE
K041266 · Hologic, Inc. · Aug 2004
DXL CALSCAN
K033550 · Demetech AB · May 2004
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · Hologic, Inc. · Nov 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962 · Ge Lunar Corp. · Jul 2003
CTXA HIP EXTENDED REFERENCE DATA
K030330 · Mindways Software, Inc. · Jun 2003
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554 · Ge Lunar Corp. · Dec 2002
K031991 · DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
Download PDF FDA Summary Image Analysis, Inc.