Cleared Traditional

K992246 - QCT BONE MINERAL ANALYSIS SOFTWARE

K992246 is an FDA 510(k) clearance for QCT BONE MINERAL ANALYSIS SOFTWARE, manufactured by Image Analysis, Inc.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K992246 · Image Analysis, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
59d
Days
Class 2
Risk

K992246 is an FDA 510(k) clearance for the QCT BONE MINERAL ANALYSIS SOFTWARE. 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 September 3, 1999 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Image Analysis, Inc. devices

FDA 510(k) Submission Details - K992246

510(k) Number K992246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1999
Decision Date September 03, 1999
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 86
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K992246.
PRODIGY LATERAL VIEW SOFTWARE
K000826 · Lunar Corp. · Apr 2000
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · Norland Medical Systems, Inc. · Nov 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775 · Hologic, Inc. · Oct 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992677 · Hologic, Inc. · Sep 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · Compumed, Inc. · May 1999
PRONOSCO X-POSURE SYSTEM
K984178 · Torsana Osteoporosis Diagnostics A/S · Feb 1999