Cleared Traditional

K042480 - INFANT WHOLE BODY SOFTWARE OPTION FOR Q...

K042480 is the FDA 510(k) clearance for INFANT WHOLE BODY SOFTWARE OPTION FOR Q... by Hologic, Inc.. It is a Class 2 Radiology device (product code KGI) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K042480 · Hologic, Inc. · Radiology device
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Oct 2004
Decision
46d
Days
Class 2
Risk

K042480 is an FDA 510(k) clearance for the INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on October 29, 2004 after a review of 46 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 Hologic, Inc. devices

Submission Details

510(k) Number K042480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date October 29, 2004
Days to Decision 46 days
Submission Type Traditional
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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K042480.
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K060111 · Hologic, Inc. · Apr 2006
PEDIATRIC REFERENCE DATABASE
K041266 · Hologic, Inc. · Aug 2004
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · Hologic, Inc. · Nov 2003
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · Hologic, Inc. · Nov 2002